MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ INFUSION SET (C61); ADMINISTRATION SET

Catalog Number	515302
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was not provided.Investigation conclusion: ct scan done on leaking sample which was segregated during production.After this scan additional test were done on spike component.Concentricity of lower part of spike component (spigot) which caused molding deficit on one side of component root cause description: concentricity of lower part of spike component (spigot) which caused molding deficit on one side of component capa has been initiated: capa # (b)(4).
Event or Problem Description
It was reported that leakage occurred with a bd phaseal¿ infusion set (c61).The following information was provided by the initial reporter, "pharmacist insert the secondary line c61 into the infusion bag and clamp the line after priming the tubing.During insertion of cytotoxic drug etoposide into the infusion bag, leakages occurs at the tubing area and the pharmacist stop the insertion and quickly change the secondary line c61 to avoid further wastage of the drug.Updated info: there¿s not physical harm to the user or patients due to the leakages occur.".

• Brand Name: BD PHASEAL¿ INFUSION SET (C61)
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8608011
• Report Number: 2243072-2019-00913
• Device Sequence Number: 19264610
• Product Code: FPA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 03/31/2022
• Device Catalogue Number: 515302
• Device Lot Number: 1010228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/14/2019
• 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