MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE MINIMED® PRO-SET® BD FLOWSMART¿ TECHNOLOGY, 24IN X 6MM P-CAP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 328614

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of a minimed® pro-set® bd flowsmart¿ technology, 24in x 6mm p-cap the needle was bent and would not deliver insulin.

Manufacturer Narrative

Investigation: there were no relevant quality notifications raised which may have contributed to bent cannula found during dhr review.Since there were no samples (or photos) for investigation, unable to confirm the reported issue and the actual root cause is undetermined.

Event Description

It was reported that during use of a minimed® pro-set® bd flowsmart¿ technology, 24 in x 6mm p-cap the needle was bent and would not deliver insulin.

• Brand Name: MINIMED® PRO-SET® BD FLOWSMART¿ TECHNOLOGY, 24IN X 6MM P-CAP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8344429
• MDR Text Key: 137285958
• Report Number: 1920898-2019-00163
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 00382903286140
• UDI-Public: 00382903286140
• Combination Product (y/n): N
• PMA/PMN Number: K160651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 328614
• Device Lot Number: 6207535
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other