MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS 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	06/13/2019
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 is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd phaseal¿ protectors p53 it is difficult to inject air and draw the drug.This occurred on 10 separate occasions but the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: customer complained when using p53, some lot are hard to inject air and draw drug.
Event or Problem Description
It was reported that during use of the bd phaseal¿ protectors p53 it is difficult to inject air and draw the drug.This occurred on 10 separate occasions but the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from japanese to english: customer complained when using p53, some lot are hard to inject air and draw drug.
Additional Manufacturer Narrative
H.6.Investigation: two unused samples from lot 1604018 and one unused product from lot 1503022 were returned to our quality team for investigation.A device history review was performed for report lot 1604018, no deviations or non-conformances related to this issue were identified during the manufacturing process.Functional testing was performed on all samples received and all product functioned as intended.There was no resistance noted when injecting air or withdrawing fluid during these tests, no difference was identified in the performance or functionality of the product from either lot.Based on the available information we are not able to determine a root cause at this time.

• Brand Name: BD PHASEAL¿ PROTECTORS 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: 8761102
• Report Number: 3003152976-2019-00444
• Device Sequence Number: 11336843
• 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): 08/05/2019

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: 1604018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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