MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE 1ML, 30G X 8MM

Catalog Number 328328

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation: a sample is not available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the suspect device broke in the patient's abdomen during an insulin injection and remained in the site.The patient received an x-ray and an ultrasound (date unknown) but the needle was not detected.The patient returned to her doctor on (b)(6) 2016 for an additional ultrasound.The needle was detected 1.5 mm below the skin.The doctor decided not to do surgery at this time and told the patient her body would expel the needle on its own.No additional interventions were provided at this time.The patient denies reuse of the device.

Manufacturer Narrative

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 4209800.This device was packaged between 9/9/2014 and 9/10/2014.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE 1ML, 30G 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: 5880565
• MDR Text Key: 52272728
• Report Number: 1920898-2016-00025
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 328328
• Device Lot Number: 4209800
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR