MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PEARL SIDE ENTRY PATIENT ROOM COLLECTOR; SHARPS COLLECTOR

Catalog Number	305444
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 the lids received with the bd¿ pearl side entry patient room collectors were the wrong size, and noticed before use.The customer reported 20 occurrences of this event.The following information was provided by the initial reporter: "wrong lids.".
Additional Manufacturer Narrative
H.6.Investigation: the actual product was returned, and photo representation was provided.A review of the dhr showed there were no issues reported like incorrect lids during the manufacturing process.A review of the nonconformance material reports was performed and the result showed there were no issues reported for the same part number throughout the last twelve months.According to the evidence provided, the issue seems to be related to an incorrect subassembly (box of lids) supplied, which is a manufacturing issue.In conclusion, during the ongoing investigation of this complaint, the same failure mode occurred in the manufacturing process and the number of occurrences required a risk assessment and as a result a capa record was opened to implement corrective action(s) to avoid or decrease any recurrences for this issue (incorrect lid).H3 other text : see section h.10.
Event or Problem Description
It was reported that the lids received with the bd¿ pearl side entry patient room collectors were the wrong size, and noticed before use.The customer reported 20 occurrences of this event.The following information was provided by the initial reporter: "wrong lids".

• Brand Name: BD¿ PEARL SIDE ENTRY PATIENT ROOM COLLECTOR
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8883779
• Report Number: 2243072-2019-01669
• Device Sequence Number: 1642582
• Product Code: FMI
• UDI-Device Identifier: 50382903054447
• UDI-Public: 50382903054447
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 305444
• Device Lot Number: 8274909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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