MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE; PISTON SYRINGE

Catalog Number 324912

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a needle break occurred during use with a bd veo¿ insulin syringe with bd ultra-fine 6mm needle.The following information was provided by the initial reporter, from phone call on (b)(6) 2019 10:14:02: consumer returned call.She stated when she pulled the syringe from the skin site, she noticed the needle had broken inside her body.It was not on the floor.By looking at the syringe now she can see the residue on the syringe as it has broken.She went to urgent care.The doctor could not see anything on xray.Doctor referred her to visit the surgeon, she stated they used the metal machine to look up and did not see anything.Surgeon stated that if it is still in the body, she could probably get infected.Once the skin turns red they can try to remove it.Doctor wants her to call back on (b)(6) 2019.Item# 324912; lot#8239852g.Occurence-1.Sample available.She uses the new syringes each time of her injection, she visually tests the needle to see if it is straight.She rotates the injection site.She has been using insulin for about 9 to 10 years.She is concerned about this hopefully, this does not reoccur.Offered to send the voucher.(bea) offered to follow up.'.

Manufacturer Narrative

H.6.Investigation summary: customer returned (1) loose 1cc syringe.Customer states that the needle broke in the injection site.The returned syringe was examined and exhibited a broken cannula.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end and cracked adhesive.When viewed together, these are all indicators of bending/re-straightening mode of failure.A review of the device history record was completed for batch# 8239852.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.User error.Bending/re-straightening mode of failure by the customer.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.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.

Event Description

It was reported that a needle break occurred during use with a bd veo¿ insulin syringe with bd ultra-fine 6mm needle.The following information was provided by the initial reporter, from phone call on (b)(6)2019 10:14:02: consumer returned call.She stated when she pulled the syringe from the skin site, she noticed the needle had broken inside her body.It was not on the floor.By looking at the syringe now she can see the residue on the syringe as it has broken.She went to urgent care.The doctor could not see anything on xray.Doctor reffered her to visit the surgeon, she stated they used the metal machine to look up and did not see anything.Surgeon stated that if it is still in the body, she could probably get infected.Once the skin turns red they can try to remove it.Doctor wants her to call back on (b)(6)2019.Item# 324912; lot#8239852g.Occurence-1 sample available.She uses the new syringes each time of her injection, she visually tests the needle to see if it is straight.She rotates the injection site.She has been using insulin for about 9 to 10 years.She is concerned about this hopefully, this does not re occure.Offered to send the voucher.(bea) offered to follow up.'.

Event Description

It was reported that a needle break occurred during use with a bd veo¿ insulin syringe with bd ultra-fine 6mm needle.The following information was provided by the initial reporter, from phone call on 2019-09-10 10:14:02: consumer returned call.She stated when she pulled the syringe from the skin site, she noticed the needle had broken inside her body.It was not on the floor.By looking at the syringe now she can see the residue on the syringe as it has broken.She went to urgent care.The doctor could not see anything on xray.Doctor refered her to visit the surgeon, she stated they used the metal machine to look up and did not see anything.Surgeon stated that if it is still in the body, she could probably get infected.Once the skin turns red they can try to remove it.Doctor wants her to call back on 09-11-2019.Item# 324912; lot#8239852g.Occurence-1 sample available.She uses the new syringes each time of her injection, she visually tests the needle to see if it is straight.She rotates the injection site.She has been using insulin for about 9 to 10 years.She is concerned about this hopefully, this does not reoccurred.Offered to send the voucher.(bea) offered to follow up.'.

Manufacturer Narrative

Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8239852.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9126136
• MDR Text Key: 166038603
• Report Number: 1920898-2019-01044
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 324912
• Device Lot Number: 8239852
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention