MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100J; ADMINISTRATION SET

Catalog Number 515310

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problems Chemical Exposure (2570); Radiation Exposure, Unintended (3164)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a patient was receiving and infusion of endoxan (chemotherapy) and the needle of a bd phaseal¿ infusion adapter c100j detached causing the medication to leak.The patient's bare skin was exposed to the endoxan but the physician immediately wiped it off.There was no report of medical intervention.

Manufacturer Narrative

A sample is not available for evaluation, however, photos of the affected device were returned for investigation.A photo inspection showed no abnormality to the bd phaseal¿ infusion adapter c100j spike needle and that the rubber of the infusion bag was not punctured in any of the three entry locations designated for it, but rather in the middle of the three.Additionally, no leakage was confirmed.A review of the device history record could not be performed as a lot number was not provided for this incident.Without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Additionally, the photos revealed improper handling of the bd phaseal¿ infusion adapter c100j and infusion bag.

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100J
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6515971
• MDR Text Key: 73734714
• Report Number: 3003152976-2016-00016
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 515310
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other