MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2ML BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH 28G X 1/2" BD MICRO-FINE¿ NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number 329461

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.However, a review of the device history record has been completed and no defects or notifications during manufacturing were identified for the reported lot # 6039545.Conclusion: a conclusion is not yet available as the evaluation is still in progress.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a 1/2 ml bd lo-dose¿ u-100 insulin syringe with 28 g x 1/2 in.Bd micro-fine¿ iv permanently attached needle broke of in a cat's hip during a spay surgery.The cat received an x-ray and the broken needle was visualized.The doctor is not sure if the needle can be removed and will consult another veterinary surgeon.

Manufacturer Narrative

Results: three samples; one loose and two in sealed blister packs were returned for evaluation.All returned syringes were examined and the loose sample exhibited a broken cannula.A microscopic examination of the returned sample with the broken cannula revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.As previously reported, a review of the device history record revealed no defects or notifications during manufacturing for the reported lot # 6039545.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 1/2ML BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH 28G X 1/2" BD MICRO-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: 6500500
• MDR Text Key: 73058886
• Report Number: 1920898-2017-00048
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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: Other
• Device Catalogue Number: 329461
• Device Lot Number: 6039545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention