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

Catalog Number	515302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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 bottle and clamp the line after priming the tubing.During insertion of cytotoxic drug rituximab into the infusion bottle, there's no leakages observed.During administration of the drug to patient, the nurse in charges notice there's leakages occurs and the infusion bottle was then return to the pharmacy to exchange a new secondary set to avoid wastage of the drug.The faulty secondary set was kept and available to clarify for the leakage by the pharmacist.The leakages occurs does not harm either the nurse or the patient.The pharmacist and nurse are using the product and there¿s not physical harm to the user or patient 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 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 caused molding deficit on one side of component.Capa#891423 was initiated.
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 bottle and clamp the line after priming the tubing.During insertion of cytotoxic drug rituximab into the infusion bottle, there's no leakages observed.During administration of the drug to patient, the nurse in charges notice there's leakages occurs and the infusion bottle was then return to the pharmacy to exchange a new secondary set to avoid wastage of the drug.The faulty secondary set was kept and available to clarify for the leakage by the pharmacist.The leakages occurs does not harm either the nurse or the patient.The pharmacist and nurse are using the product and there¿s not physical harm to the user or patient due to the leakage.".

• 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: 8632307
• Report Number: 2243072-2019-00982
• Device Sequence Number: 13922097
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 515302
• Device Lot Number: 1011186
• 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: 06/05/2019
• 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