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

Model Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown, device manufacture date: unknown.(b)(4).Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no lot information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
Event or Problem Description
It was reported that 6 bd phaseal¿ protectors p53 experienced leakage between the protector and vial during use.The following information was provided by the initial reporter: leakage between vial and protector (p53) when preparing piperacillin/tazobactam.This has happened at least 6 times.Customer could not tell what lot no it is.Normally they are using p21 for smaller drug vials with diameter 20 mm.Now this size is on back order they have instead received larger vials with diameter 32 mm and therefore need the p53 protector to fit.These vials are from (b)(6), with (b)(6) labeled vials.No photos available and the used protectors have been thrown away.

• 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: 10348463
• Report Number: 3003152976-2020-00335
• Device Sequence Number: 19694686
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/30/2020
• 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