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	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 leaked.This occurred on 3 occasions.The following information was provided by the initial reporter: leakage from c61 they have noticed the leakage at pharmacy right after sytostatic preparation.Leakage comes from tubing (the contact part to spike).They have realized same kind of problems earlier this month, but haven¿t been reporting those.
Additional Manufacturer Narrative
H.6.Investigation: 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 this scan additional tests were done on spike component and concentricity of lower part of spike component which caused molding deficit on one side of component.Capa#891423 was initiated.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 leaked.This occurred on 3 occasions.The following information was provided by the initial reporter: leakage from c61 they have noticed the leakage at pharmacy right after sytostatic preparation.Leakage comes from tubing (the contact part to spike).They have realized same kind of problems earlier this month, but haven¿t been reporting those.

• 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: 8632607
• Report Number: 2243072-2019-00987
• Device Sequence Number: 19355580
• Product Code: FPA
• UDI-Device Identifier: 00382905153020
• UDI-Public: 382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 06/10/2019

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 515302
• Device Lot Number: 1011580
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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