MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE 9GAL GASKET RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305602
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Medical device expiration date: n/a.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that sharps coll slide close 9gal gasket red was missing the label.The following information was provided by the initial reporter: material no: 305602, batch no: 8322927.It was reported that 1 case of containers were missing the white un label.We did come across 1 case where the containers were missing the white un label.I advised of this and have put the 1 case off to the side.I advised that the un code is a us requirement and the containers are still sellable.As such, we will not be returning the affected product.
Additional Manufacturer Narrative
It was reported one case of containers were missing the white un label.A sample nor photo representation were provided for evaluation.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing label during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.There is not enough information provided like a picture from the missing label to determine or confirm the root cause of this non-conformance.However, the lack of label is an issue directly related to manufacturing process and is considered an omission error during the manufacturing process.A complaint review for the last twelve months did not identify any other reported complaint for the related issue.The label is 100% visually inspected by production and a second inspection based on an aql sampling plan is performed by quality inspectors.As preventive action a quality alert will be posted within the manufacturing process for this product line.Bd will continue to monitor for any trends.
Event or Problem Description
It was reported that sharps coll slide close 9gal gasket red was missing the label.The following information was provided by the initial reporter: material no: 305602 batch no: 8322927.It was reported that 1 case of containers were missing the white un label.We did come across 1 case where the containers were missing the white un label.I advised of this and have put the 1 case off to the side.I advised that the un code is a us requirement and the containers are still sellable.As such, we will not be returning the affected product.

• Brand Name: SHARPS COLL SLIDE CLOSE 9GAL GASKET RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8624023
• Report Number: 2243072-2019-00967
• Device Sequence Number: 1858320
• Product Code: FMI
• UDI-Device Identifier: 50382903056021
• UDI-Public: 50382903056021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943575
• 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): 06/26/2019

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 Catalogue Number: 305602
• Device Lot Number: 8322927
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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