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

Catalog Number	515302
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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.(b)(4).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.The following information was provided by the initial reporter: for (b)(6) 2019 case, priming was done and during the usual check, no leakage occurred.It was later after the drug (uromitexan, non-cytotoxic) was added into the bottle, that the leakage manifested.We managed to salvage the preparation by plugging the port with c90 and using another port (otherwise the whole preparation would be unusable).The affected c61 was pulled out and stuck into another partial ¿clean¿ drip bottle (containing sterile water).The pharmacist is using the product and there¿s not physical harm to the user or patients due to the leakage.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 leaked.The following information was provided by the initial reporter: for 17/4/2019 case, priming was done and during the usual check, no leakage occurred.It was later after the drug (uromitexan, non-cytotoxic) was added into the bottle, that the leakage manifested.We managed to salvage the preparation by plugging the port with c90 and using another port (otherwise the whole preparation would be unusable).The affected c61 was pulled out and stuck into another partial ¿clean¿ drip bottle (containing sterile water).The pharmacist is using the product and there¿s not physical harm to the user or patients due to the leakage.
Additional Manufacturer Narrative
Investigation: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was provided.Ct scan was done on a leaking sample which was segregated during production.After this scan additional tests were done on spike component and the 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: 8577991
• Report Number: 2243072-2019-00845
• Device Sequence Number: 19318077
• Product Code: LHI
• UDI-Device Identifier: 00382905153020
• UDI-Public: 382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 515302
• Device Lot Number: 1011186
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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