MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE

Catalog Number 326631

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date : unknown.Initial reporter phone# : (b)(6).Initial reporter zip code : (b)(6).Medical device manufacture date : unknown.Investigation summary : exec summary: samples were received and an investigation was performed.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Samples returned: customer returned (1) loose 3/10cc syringe.Customer states that the shield was deformed and could not be detached.The returned syringe was examined and exhibited a disfigured shield which could prevent the shield from being properly removed.Manufacturing (holdrege) will be notified of this issue.Photos: 17aug2021 holdrege received a photo complaint but batch was unknown: initial evaluation: examination of the photo indicates that the shield was damaged or pinched on two thirds of the shield.There is no photo to determine if the cannula was affected.With the shield being damaged it is believed the nonconformance would have had to occur at the form, fill and seal (ffs) operation.It is unknown which ffs did cause the defect as no packaging material was identified in the complaint.Manufacturing evaluation: a review of the syringe assembly line was not completed as batch was unknown.Process summary: the automatic syringe assembly machine which feeds 0.3ml syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components into a syringe.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Device history record; l2l and logbook evaluation: dhr, l2l dispatches, logbook entries could not be looked at as no lot number was given.Root cause: root cause for this defect cannot be determined.Capa/sa - based on the above investigation no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - no dhr review can be carried out as the lot number is unknown.

Event Description

It was reported that 2 bd syringe 0.3ml 29ga 1/2in had shield sterility issues.The following information was provided by the initial reporter : the customer reported that the shield was deformed and could not be detached.

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12363167
• MDR Text Key: 268039069
• Report Number: 1920898-2021-00925
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

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: Lay User/Patient
• Device Catalogue Number: 326631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/24/2021
• 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