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

Model Number	305076
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap had a damaged lid.The following information was provided by the initial reporter: " during inspection, the customer discovered that the lid was damaged at the joint area and detached.".
Additional Manufacturer Narrative
H6: investigation summary: no photo or sample was received with the customer's complaint of lid damaged.Without further information, the root cause remains unknown.No ncr's were reported in the production of the lot described.A device history review was conducted for lot number 0272002.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap had a damaged lid.The following information was provided by the initial reporter: " during inspection, the customer discovered that the lid was damaged at the joint area and detached.".

• 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: 12208119
• Report Number: 2243072-2021-01947
• Device Sequence Number: 3840051
• Product Code: FMI
• UDI-Device Identifier: 50382903050760
• UDI-Public: 50382903050760
• 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): 10/06/2021

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 Model Number: 305076
• Device Catalogue Number: 305076
• Device Lot Number: 0272002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1