MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CAP FOR INJECTOR MEMBRANE M50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515404
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 cap for injector membrane m50 had foreign matter.The following information was provided by the initial reporter: this is a report about foreign matter on 515404.According to the customer's report, white powder-like fm on 515404 was found.
Event or Problem Description
It was reported that cap for injector membrane m50 had foreign matter.The following information was provided by the initial reporter: this is a report about foreign matter on 515404.According to the customer's report, white powder-like fm on 515404 was found.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 1805103.D4: medical device expiration date: 2023-04-30.D4: udi # (b)(4).D10: device available for eval yes.D10: returned to manufacturer on: 2021-04-27.G.5.Pma/510(k)#: k092782.H4: device manufacture date: 2018-05-11.H6: investigation summary one injector cap from lot 1805103 was provided to our quality engineer for evaluation.Upon inspecting the product, white particles can be observed on the surface of the product as well as inside the packaging.Three retained samples of the same lot were used for additional evaluation.After inspecting the product, no particles were observed on the caps or within the packages.A device history review was performed for lot 1805103, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Sterilization testing was performed and results were found to be within specification.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.Based on our investigations the particles were identified to consist of tyvek paper which is used in the packaging for this product.These particles can accumulate in the rollers from the packaging line as the paper passes through and likely fell into the blister package before they were sealed.

• Brand Name: CAP FOR INJECTOR MEMBRANE M50
• 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: 11773886
• Report Number: 3003152976-2021-00249
• Device Sequence Number: 4168188
• Product Code: ONB
• UDI-Device Identifier: 00382905154041
• UDI-Public: 00382905154041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/10/2021

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 515404
• Device Lot Number: 1805103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1