MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION SET C50

Catalog Number 515300

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd phaseal¿ infusion set c50 the package was open in two places on one side.

Manufacturer Narrative

Investigation summary: a device history review was performed and found no non-conformances associated with this issue during the production of this batch.One sample was received for investigation at sendai facilities.Issue is confirmed as the tubing appear cutting in the sealing area of the unit packaging.Visual inspection of the sample confirmed the issue.One unit appear to be opened by one side due a bad disposition of the set into the blister.Both drip chamber cap and male luer lock cap have been placed too close to the sealing area of the film+paper, resulting in the issue detected by the customer.The set is manually assembled and then is inserted into the blister machine, which seals the film and paper to form the unit package.Finally, one packaging operator inserts the sets into a carton box.Manpower could be considered as part of the root cause of the problem as the operator did not correctly place the set into the blister machine, placing the tubing in the sealing area of the blister packaging.Furthermore, take into account the result of the visual inspection, it could be that a defective unit was not detected during packaging or during quality controk, as this is done according to a sampling plan.Inspections and test: inspections an test are performed by sendal according to sb1739.Take into account the complaints trend history (no related complaints) and the result of the visual inspection of the sample the most probably root cause could be a punctual bad disposition of the set into the blister produced by one operator.

Event Description

It was reported that before use of the bd phaseal¿ infusion set c50 the package was open in two places on one side.

• Brand Name: BD PHASEAL¿ INFUSION SET C50
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8261265
• MDR Text Key: 133851268
• Report Number: 3003152976-2019-00003
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: 515300
• Device Lot Number: TA10662
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other