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

Catalog Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that one protector p53 has been found experiencing leakage during use.The following has been provided by the initial reporter: cisplatin(chemo) leaked from between p53 and the vial.Hcp commented that the p53 fits properly.
Additional Manufacturer Narrative
H.6.Investigation: one sample was received for evaluation.Upon examination, the leak between the protector and the vial was verified.The protector was fitted to vial in an inclined position.Air leaked between protector and vial so bladder did not work.After reconnected, the expansion chamber worked properly and no leak was found between the protector and the vial.A device history record could not be evaluated as the lot number is unknown.Based upon the investigation of the sample received and the investigation, the root cause of this incident is related to how the protector was fitted to the vial in an inclined position.The protector must be attached completely vertical.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.H3 other text : see h.10.
Event or Problem Description
It has been reported that one protector p53 has been found experiencing leakage during use.The following has been provided by the initial reporter: cisplatin(chemo) leaked from between p53 and the vial.Hcp commented that the p53 fits properly.

• 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: 9112620
• Report Number: 3003152976-2019-00664
• Device Sequence Number: 11270233
• 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): 11/27/2019

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 Catalogue Number: 515107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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