MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN PISTON SYRINGE

Catalog Number 328821

Device Problem Defective Device (2588)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a complaint history check was performed and this is the 1st related complaint for hub damaged (curved syringe hub) on lot # 0153021. Investigation summary: customer returned (3) 1/2cc, 8mm syringes. Customer states that the syringe hub is curved. The returned syringes were examined and no defects were observed on the returned samples. The customer also returned a photo which was also examined. The photo exhibited a syringe with a slightly tilted hub/shield assembly, indicating that there may be a slightly deformed barrel tip. A review of the device history record was completed for batch# 0153021. All inspections and challenges were performed per the applicable operations qc specifications. There was one (1) notification [200895749] noted that did not pertain 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 (deformed barrel tip) on 25feb2021, holdrege received a complaint, via a picture, from material 328468, batch 0153021 syringe 0. 5ml 30g 8mm. Initial evaluation: visual inspection of the picture showed a syringe with a attached needle assembly unit slightly tilted on the barrel indicating a damaged barrel tip. Process summary: process summary: blank barrels are transferred from totes to a bulk hopper, the hopper then transports them into the vibratory feeder which orients and transfers the barrels single file into the first inline feeder. The first inline feeder rail transfers to the inspection dial where short molding defects are rejected. After the inspection dial, the barrels are transferred to the second inline feeder and transitions through the corona treater terminating at the inhibit gate. At cycle start, the inhibit gate opens, introducing barrels to printer infeed dial on through the flange guide which aligns the flanges for proper registration and into the print carousel where ink images are applied. From the print carousel, the barrels are transitioned to the transfer dial and into the curing oven. The cured product exits the oven chute for transfer to the next operation. Device history record; l2l and logbook evaluation: the device history (dhr) for batch 0153021 was reviewed and zero quality notifications were written for issues relating to the syringe defect. During the manufacturing process, the following inspections are completed on regular intervals: visual inspection every 30 minutes: damaged barrel defects that affect sterility barrier or functionality. Visual inspection every 30 minutes: damaged barrel defects that do not affect sterility barrier or functionality. If a defect is found during an inspection a quality notification is initiated root cause: l2l maintenance dispatch #102220 damaged barrel tip was generated on 25jul2020 on ch printer. Corrective action: the infeed dial was adjusted.

Event Description

It was reported that 3 syringe 0. 5ml 31ga 8mm tw 10bag 500 twn were damaged at an unspecified time. The following was reported by the initial reporter: "curved syringe hub".

• Brand Name: SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11404982
• MDR Text Key: 242285582
• Report Number: 1920898-2021-00252
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 328821
• Device Lot Number: 0153021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial