MAUDE Adverse Event Report: BECTON DICKINSON BD WINGSET SLBCS 25X.75 7LUER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367294
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use the sleeve falls off with a bd wingset slbcs 25x.75 7luer.The following information was provided by the initial reporter: it is reported by customer plastic sleeve covering needle came off before use.
Additional Manufacturer Narrative
H.6.Investigation summary bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to the sleeve/cover coming off as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.H3 other text : see section h.10.
Event or Problem Description
It was reported that prior to use the sleeve falls off with a bd wingset slbcs 25x.75 7luer.The following information was provided by the initial reporter: it is reported by customer plastic sleeve covering needle came off before use.

• Brand Name: BD WINGSET SLBCS 25X.75 7LUER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9475585
• Report Number: 2243072-2019-02828
• Device Sequence Number: 501837
• Product Code: JKA
• UDI-Device Identifier: 50382903672948
• UDI-Public: 50382903672948
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• 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): 03/10/2020

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 Expiration Date: 07/31/2021
• Device Model Number: 367294
• Device Catalogue Number: 367294
• Device Lot Number: 8G04A1
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 03/10/2020
• 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