MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA 7.6L FUNNEL YELLOW; SHARPS COLLECTOR

Catalog Number	300440
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Device evaluated by mfr: 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 (b)(6) 7.6l funnel yellow lids had no teeth.This occurred on 96 occasions.The following information was provided by the initial reporter: sharp lids without teeth.Updated info: photos of the carton box in where the product was received ¿ no longer available but customer are able to return physical sample.Quantity of product ordered by the customer ¿ customer bought one whole case.
Event or Problem Description
It was reported that sharps coll canada 7.6l funnel yellow lids had no teeth.This occurred on 96 occasions.The following information was provided by the initial reporter: sharp lids without teeths.Updated info: 1.Photos of the carton box in where the product was received ¿ no longer available but customer are able to return physical sample.2.Quantity of product ordered by the customer ¿ customer bought one whole case.
Additional Manufacturer Narrative
H.6.Investigation: according to the dhr review process; the result showed there were no issues reported like incorrect lids during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like incorrect lids for the same part number throughout the last twelve months.According with this investigation a mixed material is a failure mode related to manufacturing process however, no samples or pictures were provided to perform an exhaustive investigation in order to rule out that this issue was generated due to incorrect handling, repackaging process or a partial sale performed by distributor.Based on information provided was not possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information like a picture of the original packaging to perform an exhaustive investigation.H3 other text : see h.10.

• Brand Name: SHARPS COLL CANADA 7.6L FUNNEL YELLOW
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8712384
• Report Number: 2243072-2019-01213
• Device Sequence Number: 14535566
• Product Code: MMK
• UDI-Device Identifier: 00382903004409
• UDI-Public: 382903004409
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 300440
• Device Lot Number: 8143927
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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