MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50J; INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that the unspecified bd phaseal¿ protector was damaged.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the protector cracked and damaged.When attaching the protector to the vial, damage to the protector was observed.The reportec product was p55, but it may be p50j.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-jun-2023.H6: investigation summary: one sample was provided to our quality team for investigation.The product was visually inspected, observing the protector was cracked around the connection to the vial.It was also noted that not all of the plastic wrapping was removed from around the vial, increasing the diameter of the vial neck which can create resistance when attaching the protector.Dimensional testing was performed on the vial and the diameter of the vial was found to be 20.50 mm, which is above the recommended size for the protector used.Product undergoes visual and functional testing throughout manufacturing to ensure the quality and functionality of the device, including leakage testing and verification all critical dimension are within specification.As lot information for this incident was not available, a device history review could not be performed.Based on the sample investigation, the root cause of this incident is related to the incorrect vial size for the protector that was used, measuring larger than specification for the protector used, requiring greater force when attempting to connect the protector on to the vial which ultimately caused it to break.
Event or Problem Description
It was reported that the bd phaseal protector p50j was damaged.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the protector cracked and damaged.When attaching the protector to the vial, damage to the protector was observed.
Event or Problem Description
It was reported that the bd phaseal protector p50j was damaged.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the protector cracked and damaged.When attaching the protector to the vial, damage to the protector was observed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5: describe event or problem: it was reported that the bd phaseal protector p50j was damaged.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the protector cracked and damaged.When attaching the protector to the vial, damage to the protector was observed.D1: medical device brand name: bd phaseal protector p50j.D2: medical device manufacturer: becton dickinson, s.A.D4: udi #: (b)(4).D4: medical device catalog #: 515111.G2: manufacturing location: (b)(4).G.5.Pma / 510(k)#: k130197.

• Brand Name: BD PHASEAL PROTECTOR P50J
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca NJ 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix NJ 07417
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17282821
• Report Number: 2243072-2023-01182
• Device Sequence Number: 17467030
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 515117
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 08/29/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/20/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown