MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ SECONDARY SET C61; ADMINISTRATION SET

Catalog Number	515302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: unknown.(b)(6).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 was leaking.The following information was provided by the initial reporter: leaking c62 - more information required.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 was leaking.The following information was provided by the initial reporter: leaking c62 - more information required.
Additional Manufacturer Narrative
Dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was not provided.Ct scan was done on leaking sample which was segregated during production.After the scan additional tests were done on spike component and concentricity of lower part of spike component caused molding deficit on one side of component.Capa#891423 was initiated.

• Brand Name: BD PHASEAL¿ SECONDARY SET C61
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8658420
• Report Number: 2243072-2019-01058
• Device Sequence Number: 11320839
• Product Code: FPA
• UDI-Device Identifier: 00382905153020
• UDI-Public: 382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: Other
• Device Catalogue Number: 515302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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