MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305551
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ sharps collectors carton label was torn.This occurred with 5 products.The following information was provided by the initial reporter: "during the pre-delivery inspection at the distributor's side, the label on the carton was found to be torn in five products.".
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.Initial reporter e-mail: unknown.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 bd¿ sharps collectors carton label was torn.This occurred with 5 products.The following information was provided by the initial reporter: "during the pre-delivery inspection at the distributor's side, the label on the carton was found to be torn in five products.".
Additional Manufacturer Narrative
H6.Investigation summary: no samples or pictures were received as evidence.Customer confirmed there was no more additional information available.According to the dhr review, during the manufacturing process no issues were reported torn label for the lot number reported under this complaint (2026963).A review of the ncmr¿s was performed; the results exhibit no issues reported for the same part number and issue throughout the last twelve months.As part of this investigation, there is not enough evidence like a picture showing the issue reported, however with the lot number provided we can confirm that this product was manufactured by flex in january 2022.According with this investigation, this is a failure mode that could potentially be related to the manufacturing process since there is a possibility of improper manual handling by the operator at the time to perform the packaging process, however this kind of damages could also be generated by different conditions like incorrect packaging and incorrect handling by distributors.Based on the information provided it was not possible to confirm the root cause of this issue since additional information is needed.

• Brand Name: BD¿ SHARPS COLLECTOR
• 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: 15573383
• Report Number: 2243072-2022-01751
• Device Sequence Number: 6077285
• Product Code: FMI
• UDI-Device Identifier: 00382903055517
• UDI-Public: (01)00382903055517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943141
• 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): 10/27/2022

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: Other
• Device Model Number: 305551
• Device Catalogue Number: 305551
• Device Lot Number: 2026963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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