MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT; PISTON SYRINGE

Catalog Number 324909

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that an unspecified number of unspecified bd syringes separated from the hub during use.The following was reported by the initial reporter: "it was reported that needle hub separated from the syringe.Verbatim: photos attached sent: saturday (b)(6) 2021, 5:07 pm.I am a diabetic, and as such am prescribed insulin syringes for subcutaneous injections.Though sizes of needles have changed over the years, i have been prescribed and used bd syringes for 10+ years.In the past 2 weeks i've had a number of incidences with these syringes which have never been an issue before; specifically the plastic head/needle of the syringe becoming detached, either when attempting to open, or coming out that way straight from the bag.About 2 weeks ago but happened back to back at work, when i only had 2 syringes on my person to get me through the day.The first one came off as i was attempting to open the cap, the other in my pocket had become detached just from bumping against my leg.Fortunately i was able to reattach the head and use it for my needed dose, but understand doing so is not a sanitary option.For what it may help i can provide any batch/serial numbers you may want from the box itself, but i wanted to voice my concern about this recent trend, see if this is a common occurence, and see if i might be able to have these few replaced.Thank you for your time, and help.".

Event Description

It was reported that an unspecified number of syringe 0.3ml 31ga 6mm wholeunit separated from the hub during use.The following was reported by the initial reporter: "it was reported that needle hub separated from the syringe.Saturday, on (b)(6) 2021 5:07 pmi am a diabetic, and as such am prescribed insulin syringes for subcutaneous injections.Though sizes of needles have changed over the years, i have been prescribed and used bd syringes for 10+ years.In the past 2 weeks i've had a number of incidences with these syringes which have never been an issue before; specifically the plastic head/needle of the syringe becoming detached, either when attempting to open, or coming out that way straight from the bag.About 2 weeks ago but happened back to back at work, when i only had 2 syringes on my person to get me through the day.The first one came off as i was attempting to open the cap, the other in my pocket had become detached just from bumping against my leg.Fortunately i was able to reattach the head and use it for my needed dose, but understand doing so is not a sanitary option.For what it may help i can provide any batch/serial numbers you may want from the box itself, but i wanted to voice my concern about this recent trend, see if this is a common occurence, and see if i might be able to have these few replaced.Thank you for your time, and help.".

Manufacturer Narrative

The event description, medical device brand name, common device name, medical device type, device expiration date, device manufacture date, unique identifier number, pma/510(k)#, and device manufacture date have been updated.The following information has been updated: b.5.Describe event or problem: it was reported that an unspecified number of syringe 0.3ml 31ga 6mm wholeunit separated from the hub during use.The following was reported by the initial reporter: "it was reported that needle hub separated from the syringe.Saturday, on (b)(6) 2021 5:07 pmi am a diabetic, and as such am prescribed insulin syringes for subcutaneous injections.Though sizes of needles have changed over the years, i have been prescribed and used bd syringes for 10+ years.In the past 2 weeks i've had a number of incidences with these syringes which have never been an issue before; specifically the plastic head/needle of the syringe becoming detached, either when attempting to open, or coming out that way straight from the bag.About 2 weeks ago but happened back to back at work, when i only had 2 syringes on my person to get me through the day.The first one came off as i was attempting to open the cap, the other in my pocket had become detached just from bumping against my leg.Fortunately i was able to reattach the head and use it for my needed dose, but understand doing so is not a sanitary option.For what it may help i can provide any batch/serial numbers you may want from the box itself, but i wanted to voice my concern about this recent trend, see if this is a common occurence, and see if i might be able to have these few replaced.Thank you for your time, and help." d.1.Medical device brand name: syringe 0.3ml 31ga 6mm wholeunit.D.1.Common device name: piston syringe.D.2.Medical device manufacturer: bd medical - diabetes care.D.2.Medical device type: fmf.D.4.Medical device catalog#: 324909.D.4.Medical device lot#: 0139079.D.4.Medical device expiration date: 2025-05-31.D.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: bd medical - diabetes care.G.5.Pma/510(k)#: k024112.H.4.Device manufacture date: bd medical - diabetes care.

Manufacturer Narrative

H.6.Imdrf annex b grid: b01, b14.H.6.Imdrf annex c grid: c20.H.6.Imdrf annex d grid: d15.H.6 investigation summary: no physical samples were received; the investigation was performed based on the photo provided.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.The reported issue was observed and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Corrective/preventative action (capa) has been initiated.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint for needle hub separates on lot # 0139079.Manufacturing (holdrege) will be notified of this issue.A review of the device history record was completed for batch # 0139079 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates, broken barrel tip) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa pr1630423 has been opened to address this issue.

Event Description

Material no.324909, batch no.0139079.It was reported that needle hub separated from the syringe.Verbatim: per us com update in snow received second email from consumer with product information, contact information and additional verbatim.Email received: 2021-02-19 19:15:18.Product name: bd veo insulin syringes with bd ultra-fine needle 6mm, lot: 0139079 b.Reason for call: faulty/defective syringe heads.Multiple popped off of syringe tube with very little pressure thank you for your time, and help.Photos attached sent: saturday, january 30, 2021 5:07 pmi am a diabetic, and as such am prescribed insulin syringes for subcutaneous injections.Though sizes of needles have changed over the years, i have been prescribed and used bd syringes for 10+ years.In the past 2 weeks i've had a number of incidences with these syringes which have never been an issue before; specifically the plastic head/needle of the syringe becoming detached, either when attempting to open, or coming out that way straight from the bag.About 2 weeks ago but happened back to back at work, when i only had 2 syringes on my person to get me through the day.The first one came off as i was attempting to open the cap, the other in my pocket had become detached just from bumping against my leg.Fortunately i was able to reattach the head and use it for my needed dose, but understand doing so is not a sanitary option.For what it may help i can provide any batch/serial numbers you may want from the box itself, but i wanted to voice my concern about this recent trend, see if this is a common occurence, and see if i might be able to have these few replaced.Thank you for your time, and help.

• Brand Name: SYRINGE 0.3ML 31GA 6MM WHOLEUNIT
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11377984
• MDR Text Key: 266943120
• Report Number: 2243072-2021-00602
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324909
• Device Lot Number: 0139079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1