MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328418

Device Problem Defective Device (2588)

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

Event Date 05/29/2021

Event Type  malfunction  

Manufacturer Narrative

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.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Customer returned (1) 1cc, 8mm, 31g syringe in an open poly bag with the shelf carton from lot # 0114733.Customer states that the needle was bent.The returned syringe was examined and exhibited a bent cannula and a deformed barrel tip.A review of the device history record was completed for batch# 0114733.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4) ] noted that did not pertain to the complaint.The customer states that the needle was bent.Photo of the sample found that the cannula & barrel tip are bent and difficult to determine if the sample shown in the photo has a dull or blunt point on the cannula.This machine inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive.It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields.Reviewed dhr records, logbooks & maintenance history from sap did not find any potential causes/ adjustments to the process.Investigation conclusion: 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.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.Root cause description: no exact root cause determined.Rationale: based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported syringe 1.0ml 31ga 8mm ufii 10bag 500cs was damaged.The following information was provided by the initial reporter: it was reported by the consumer the needle was bent and the housing holding the needle was bent.

• Brand Name: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
• 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: 12073002
• MDR Text Key: 259027131
• Report Number: 1920898-2021-00696
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: 0114733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• 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