MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Catalog Number 328468

Device Problem Defective Component (2292)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 1 bd syringe 0.5ml 31ga 8mm had product damage and plunger issues.The following information was provided by the initial reporter : the consumer reported that the thumb press is broken off and loose in the bag and that the plunger cap detached from syringe and was also loose inside of the bag.Date of event : unknown.Samples : available.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on 2021-09-13.H6: investigation summary: customer returned, a single syringe in a polybag.Labeled for 0.5ml, 31 gauge, 8mm syringes from lot 1011586.The polybag itself, notably has sparse, irregular, and nominal perforation marks that, would make tearing open the polybag difficult to accomplish with any control.The syringe inside was also, found to have had its thumbpress break off from the base of the plunger rod, with the thumbpress itself slightly warped.The break is uneven.And happened at an angle.Lastly, the plunger cap was noted, to be damaged and bent in several spots, which may have contributed to it easily separating, if not falling off from the body of the syringe.A review of the device history record was completed for batch# 1011586.All inspections and challenges were performed, per the applicable operations qc specifications.There was one (1) notification noted, that did not pertain to the complaint.Based on the samples received, bd was able to confirm the customer¿s, indicated failure of the thumbpress being broken off.

Event Description

It was reported, that 1 bd syringe 0.5ml 31ga 8mm.Had product damage and plunger issues.The following information was provided by the initial reporter: the consumer reported, that the thumb press is broken off and loose in the bag.And that the plunger cap detached from syringe.And was also loose inside of the bag.Date of event: unknown.Samples: available.

• Brand Name: SYRINGE 0.5ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12422306
• MDR Text Key: 270564815
• Report Number: 1920898-2021-00956
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: 1011586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1