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

Catalog Number 300440

Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 Description

It was reported that sharps coll (b)(4) 7.6l funnel yellow had label damage.The following information was provided by the initial reporter: damages were found during redressing checks.120pcs discovered.Defective as follows: 90 ¿ unclear printing.24 ¿ label with air trap.1 ¿ container with double label.4 ¿ container not labelled.1 ¿ container handle damaged.

Event Description

It was reported that sharps coll canada 7.6l funnel yellow had label damage.The following information was provided by the initial reporter: damages were found during redressing checks.120pcs discovered.Defective as follows: 90 ¿ unclear printing.24 ¿ label with air trap.1 ¿ container with double label.4 ¿ container not labelled.1 ¿ container handle damaged.

Manufacturer Narrative

Correction: this complaint will be cancelled.This is a duplicate complaint of pr# (b)(4), mfr report # 2243072-2018-01042 that has already been reported for malfunction.

• Brand Name: SHARPS COLL CANADA 7.6L FUNNEL YELLOW
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8704118
• MDR Text Key: 148432753
• Report Number: 2243072-2019-01195
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903004409
• UDI-Public: 382903004409
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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
• Device Operator: Other
• Device Catalogue Number: 300440
• Device Lot Number: 6334923
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other