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

Catalog Number 326631

Device Problem Defective Component (2292)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date : unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.

Event Description

It was reported that 1 bd syringe 0.3ml 29ga 1/2in had deformed stopper issues.The following information was provided by the initial reporter : it was reported by the bd employee that the stopper was deformed.

Manufacturer Narrative

H.6.Investigation: customer returned (4) loose 3/10cc, 12.7mm syringes.Customer states that the stopper was deformed.All returned syringes were examined and one sample exhibited a deformed stopper in the barrel.Unable to perform dhr check for stopper damaged/disfigured due to unknown lot number.Root cause for this defect cannot be determined.H3 other text : see h.10.

Event Description

It was reported that 1 bd syringe 0.3ml 29ga 1/2in had deformed stopper issues.The following information was provided by the initial reporter : it was reported by the bd employee that the stopper was deformed.

• Brand Name: BD 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
• MDR Report Key: 12481375
• MDR Text Key: 271693477
• Report Number: 1920898-2021-00995
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 08/24/2021
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1