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
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8344429
• Report Number: 1920898-2019-00163
• Device Sequence Number: 1833228
• Product Code: FPK
• UDI-Device Identifier: 00382903286140
• UDI-Public: 00382903286140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 328614
• Device Lot Number: 6207535
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other