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

Model Number	305076
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap lid was disconnected.This was discovered before use.The following information was provided by the initial reporter: when the customer opened the lid before use, the connection was detached.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap lid was disconnected.This was discovered before use.The following information was provided by the initial reporter: when the customer opened the lid before use, the connection was detached.
Additional Manufacturer Narrative
H.6.Investigation: an dhr was able to be performed by universal plastics on (b)(6) 2020 with the help of additional pictures and lot# of product.No issues were found.Bd has confirmed the lid to be broken off of photo evaluation.Universal plastics, on (b)(6) 2020 also requested flex to help with investigation into this issue.Universal plastics reviewed complaint with operators.At this time universal plastics is waiting for flex investigation to continue ncr.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: 9699952
• Report Number: 2243072-2020-00188
• Device Sequence Number: 10914900
• 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
• 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): 06/19/2020

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 Model Number: 305076
• Device Catalogue Number: 305076
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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