MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P28; INTRAVASCULAR ADMINISTRATION SET

Model Number	515104
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported that protector p28 had foreign matter in the vial.This was discovered during use.The following information was provided by the initial reporter: when the protector (p28) vial adapter was attached to the vial, the nurse spotted, that there was a piece of rubber in the liquid/meropenem vial.A small piece of grey something, looking like it was from the top of the vial? the nurse put the product away, and started over with a new vial and new phaseal protector.
Additional Manufacturer Narrative
H.6.Investigation: one protector attached to a vial along with an injector was returned to our quality team for investigation.The product was visually inspected and a grey particle consistent with the rubber stopper of the vial was observed inside the vial.All product was evaluated, no defects or damage observed, the protector fit securely to the vial, and there was no damage noted on the membrane or needle of the protector.It was noted the protector needle penetrated the vial stopper off center.Fragmentation testing is performed according to procedure, to evaluate any particulates generated after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples could not be investigated.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.Based on the available we are not able to identify a definitive root cause at this time.
Event or Problem Description
It was reported that protector p28 had foreign matter in the vial.This was discovered during use.The following information was provided by the initial reporter: when the protector (p28) vial adapter was attached to the vial, the nurse spotted, that there was a piece of rubber in the liquid/meropenem vial.A small piece of grey something, looking like it was from the the top of the vial? the nurse put the product away, and started over with a new vial and new phaseal protector.

• Brand Name: PROTECTOR P28
• 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: 9759098
• Report Number: 3003152976-2020-00084
• Device Sequence Number: 2611789
• Product Code: ONB
• UDI-Device Identifier: 30382905151041
• UDI-Public: 30382905151041
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 04/14/2020

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 Model Number: 515104
• Device Catalogue Number: 515104
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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