MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 324916

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ insulin syringe had missing scale markings.The following information was provided by the initial reporter, translated from portuguese: "enquiry: i bought a box of insulin needles and they have a printing fault on the application measurement scale.Usually the first lines of 0.5 and 1 iu are not printed on the syringe".

Event Description

It was reported that the unspecified bd¿ insulin syringe had missing scale markings.The following information was provided by the initial reporter, translated from portuguese: "enquiry: i bought a box of insulin needles and they have a printing fault on the application measurement scale.Usually the first lines of 0.5 and 1 iu are not printed on the syringe.".

Manufacturer Narrative

The following fields have been updated due to additional information: h.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st 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.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Manufacturer Narrative

The following fields have been updated due to additional information: b.5.Entry description: common device name updated to bd ultra-fine¿ insulin syringe.D.2a.Common device name: bd ultra-fine¿ insulin syringe.D.3.Medical device manufacturer: bd medical - diabetes care.D.4.Catalog/lot/serial #, exp date, udi #- catalog: 324916, lot: 2304334, exp.Date-30nov2027, udi (b)(4).H.4.Device manufacture date: 31oct2022.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05jan2024.G.1.Manufacturing location: bd medical - diabetes care.G.5.Pma/510(k)# na.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and 1 conformance was raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue 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.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

Event Description

It was reported that thebd ultra-fine¿ insulin syringe had missing scale markings.The following information was provided by the initial reporter, translated from portuguese: "enquiry: i bought a box of insulin needles and they have a printing fault on the application measurement scale.Usually the first lines of 0.5 and 1 iu are not printed on the syringe.".

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17967297
• MDR Text Key: 326072817
• Report Number: 2243072-2023-01897
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324916
• Device Lot Number: 2304334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/07/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 01/04/2024
• Supplement Dates FDA Received: 11/19/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1