MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 3GAL YELLOW NEW CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305076
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is hdq us (b)(4).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: 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 that sharps coll chemo 3gal yellow new cap lid was damaged.The following information was provided by the initial reporter: this is a report about a damaged lid of sharps collector.According to the customer's report, the lid was found to be damaged upon arrival.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap lid was damaged.The following information was provided by the initial reporter: this is a report about a damaged lid of sharps collector.According to the customer's report, the lid was found to be damaged upon arrival.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/14/2021.H.6.Investigation: a sample was received and tested by our quality team with the customer's complaint of damaged lid.The lid clearly presented broken hinges and the supplier was contacted for any information that would help discover the root cause of this verified complaint.The production history of this device presented no quality issues.The root cause of this failure is unknown at this time.H3 other text : see h.10.

• Brand Name: SHARPS COLL CHEMO 3GAL YELLOW NEW CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11729275
• Report Number: 2243072-2021-01258
• Device Sequence Number: 16898560
• Product Code: FMI
• UDI-Device Identifier: 00382903050765
• UDI-Public: 00382903050765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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 Catalogue Number: 305076
• Device Lot Number: 0227002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1