MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 1QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305635
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional 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 in and the (b)(4) registration number has been used for the manufacture report number.Medical device expiration date: na.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 while using bd sharps coll 1qt red the lid did not fit properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a lid issue of sharps collector.According to the customer's report, the lid did not fit to the base.The user tried with several lids but all the tested lids did not fit.
Event or Problem Description
It was reported while using bd sharps coll 1qt red the lid did not fit properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a lid issue of sharps collector.According to the customer's report, the lid did not fit to the base.The user tried with several lids but all the tested lids did not fit.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08-nov-2022 investigation summary 1 sample without lid was returned for quality investigation by the customer.As per manufacturer instructions another container lid with same dimension tried to test the product and issue replicated as mentioned by customer.According to the dhr review process, the result showed there were no issues reported as wrong lids during the manufacturing process for the lot number reported (2049930) under this complaint.A review of the ncmr¿s was performed; the result showed no issues reported for the same part number and issue throughout the last twelve months.Based on the evidence provided from customer, this issue could potentially be related to the manufacturing process due to line clearance omission at the time to withdraw defective pieces.

• Brand Name: BD SHARPS COLL 1QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15784380
• Report Number: 2243072-2022-01932
• Device Sequence Number: 3062719
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305635
• Device Catalogue Number: 305635
• Device Lot Number: 2049930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown