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

Catalog Number	515302
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 leaked.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: this particular unit is available for your collection if required.No cytotoxic drug had been in contact/inserted yet, it¿s just plain normal saline.Priming was done according to procedure.During the usual check before further disinfection, we would give the bag a squeeze to confirm if there¿s any leak.At this point, leakage was detected.Updated info: the pharmacist is using the product when incident occurred.There¿s no physical harm to the personnel for complaint associated to leakage.
Additional Manufacturer Narrative
Investigation summary: dhr review was done and no issues were reported during production of this lot.Sample received was tested for leakage and failed.Leakage was detected on spike-tube joint.Ct scan done on leaking sample which was segregated during production.After this scan additional test were done on spike component.Root cause: concentricity of lower part of spike component (spigot) which caused molding deficit on one side of component.Capa 891423 was initiated to investigate.
Event or Problem Description
It was reported that bd phaseal¿ secondary set c61 leaked.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: this particular unit is available for your collection if required.No cytotoxic drug had been in contact/inserted yet, it¿s just plain normal saline.Priming was done according to procedure.During the usual check before further disinfection, we would give the bag a squeeze to confirm if there¿s any leak.At this point, leakage was detected.Updated info: 1) the pharmacist is using the product when incident occurred.2) there¿s no physical harm to the personnel for complaint associated to leakage.

• 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: 8535868
• Report Number: 2243072-2019-00757
• Device Sequence Number: 313482
• 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,Followup
• Report Date (Section B): 06/20/2019

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: 1011102
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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