MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE 0.3ML, 31G X 8MM

Catalog Number 328512

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

The exact date of event is unknown.The date received by the manufacturer is used.This product does not have an expiration date.Evaluation: result - a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5180851.Conclusions - as there was no sample returned for evaluation, an absolute root cause for this incident cannot be determined.The sample is not available for evaluation.

Event Description

It was reported by the customer that when she injected her dog, the needle broke off and remained in injection site.The consumer brought her dog to the veterinarian who shaved the dog's fur at the site and took an x-ray.The needle was not observed on x-ray.The veterinarian told the consumer he didn't think the dog was in any danger and told the consumer to watch for any bumps that may appear near the surface of the skin because that could be the needle moving along the surface.No additional follow up was required at the time of report.

Manufacturer Narrative

Medical device catalog #: catalog number not submitted on initial mdr.

• Brand Name: BD INSULIN SYRINGE 0.3ML, 31G X 8MM
• Type of Device: INSULIN 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 ; 8015652845
• MDR Report Key: 5259721
• MDR Text Key: 32456971
• Report Number: 1920898-2015-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328512
• Device Lot Number: 5180851
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention