MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES 3/10ML 6MM (15/64") 31G U-100; PISTON SYRINGE

Catalog Number 324919

Device Problems Material Separation (1562); Material Deformation (2976)

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

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 1109192, d.4.Medical device expiration date: 30-apr-2026, h.4.Device manufacture date: 19-apr-2021.D.4.Medical device lot #: 1326350, d.4.Medical device expiration date: 31-dec-2026, h.4.Device manufacture date: 22-nov-2021.D.4.Medical device lot #: 2066145, d.4.Medical device expiration date: 31-mar-2027, h.4.Device manufacture date: 07-mar-2022.D.4.Medical device lot #: 2220410, d.4.Medical device expiration date: 31-aug-2027, h.4.Device manufacture date: 08-aug-2022.H.3.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 during use with an unspecified amount of bd insulin syringes 3/10ml 6mm the syringe is damaged and appears bent resulting in component separation.2 of 2 reported defects.The following information was provided by the initial reporter: we have purchased 324919 syringes from multiple lots and approximately since april 2022 we started seeing defective syringes in each lot we received.We saw syringe heads fall off during normal use in extreme cases of the "head gap" defect.

Event Description

It was reported that during use with an unspecified amount of bd insulin syringes 3/10ml 6mm the syringe is damaged and appears bent resulting in component separation.2 of 2 reported defects.The following information was provided by the initial reporter: we have purchased 324919 syringes from multiple lots and approximately since april 2022 we started seeing defective syringes in each lot we received.We saw syringe heads fall off during normal use in extreme cases of the "head gap" defect.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 14-jul-2023 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 no non-conformances were raised in association with this type of event for this lot.Embecta was 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.

• Brand Name: BD INSULIN SYRINGES 3/10ML 6MM (15/64") 31G U-100
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17295362
• MDR Text Key: 319033593
• Report Number: 1920898-2023-00432
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

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: 324919
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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