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	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that a small piece of gray "rubber" was seen in the "liquid/meropenem" vial attached to the protector p28 during use, and new antibiotics had to be used.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 putted the product away, and started over with a new vial and new phaseal protector"."needed to open a new bottle of antibiotics".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/27/2020.H.6.Investigation: one protector connected to a vial of meropenem was returned to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protector or protector membrane and the needle on the protector penetrated the vial stopper properly.During our evaluation, a foreign particle was observed inside the vial which is consistent with material from the rubber stopper of the vial.Fragmentation testing is performed during manufacturing 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.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 a small piece of gray "rubber" was seen in the "liquid/meropenem" vial attached to the protector p28 during use, and new antibiotics had to be used.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 putted the product away, and started over with a new vial and new phaseal ptotector" "needed to open a new bottle of antibiotics".

• 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: 9831614
• Report Number: 3003152976-2020-00129
• Device Sequence Number: 19657347
• 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): 04/30/2020

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: Health Professional
• Device Model Number: 515104
• Device Catalogue Number: 515104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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