MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P53; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515107
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 has been reported that one protector p53 has been found experiencing flow issues during use.The following has been provided by the initial reporter: when drawing cisplatin, the protector was hard draw.Even drew the drug, air got mixed.
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned to our quality team for investigation.The product was inspected, no damaged was noted but a leak was identified between the protector and vial.The protector was reconnected, the expansion bladder worked properly and liquid could move to the vial and back without issue.It was noted that the sideburns from the protector were not properly attached to the vial.A device history review was performed for reported lot 1604016, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Three retained samples of the same lot were used for additional evaluation.Functional testing was performed, connecting the protector sample to both a vial, injector, and syringe per the instructions for use provided with the product.In all cases, the protector properly snapped onto the vial, the liquid was able to be drawn from the vial with no leaks, and the product functioned as intended.Based on the available information we are not able to determine a root cause at this time.
Event or Problem Description
It has been reported that one protector p53 has been found experiencing flow issues during use.The following has been provided by the initial reporter: when drawing cisplatin, the protector was hard draw.Even drew the drug, air got mixed.

• Brand Name: PROTECTOR P53
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8874446
• Report Number: 3003152976-2019-00513
• Device Sequence Number: 19512056
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• 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): 10/14/2019

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: 03/31/2021
• Device Catalogue Number: 515107
• Device Lot Number: 1604016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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