MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 19X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305187
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 mixed product was found before use with a needle 19x1-1/2 rb tw.The following information was provided by the initial reporter, "it was informed to me that she met with the storeroom manager and they have 10 boxes, all the same lot number in which a shorter needle was packaged as a 19g x 1 1/2 needle.The shorter needle has a gray color hub vs.Brown color hub of the actual 19g x 1 1/2"." 10 occurrences were found.
Event or Problem Description
It was reported that mixed product was found before use with a needle 19x1-1/2 rb tw.The following information was provided by the initial reporter, "it was informed to me that she met with the storeroom manager and they have 10 boxes, all the same lot number in which a shorter needle was packaged as a 19g x 1 1/2 needle.The shorter needle has a gray color hub vs.Brown color hub of the actual 19g x 1 1/2"." 10 occurrences were found.
Additional Manufacturer Narrative
H.6.Investigation: approximately three thousand (3000) samples and one (1) photo were provided by the customer for investigation.The returned samples were returned in unopened blister packs and shelf cartons.Two hundred (200) samples were visually examined using unaided vision.It was observed that there were needle assemblies with the incorrect needle hub and needle mixed in with the correct needle assemblies.Additionally, one (1) photo was also provided by the customer for investigation.The photo shows two (2) shielded needle assemblies next to each other.The needle hubs appear to be different colors and the needles also appear to possibly be different lengths.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.However, during the investigation it was observed that a lot #8020473 of material #8020473 (needle 22 ga 1-1/4in) was being produced at the same time as lot #9031984 of material # 50815 (needle 19ga 1-1/2in) on two (2) needle in process (nip) lines which were located next to each other.Therefore, it is likely that one (1) bag of lot #8020473 of material #8020473 (needle 22 ga 1-1/4in) from nip 5 was placed in the gaylord for lot #9031984 of material # 50815 (needle 19ga 1-1/2in).This gaylord was then packaged on multi vac 4 (mv 4) with the mixed product getting packaged without being noticed.H3 other text : see h.10.

• Brand Name: NEEDLE 19X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9220538
• Report Number: 1911916-2019-01107
• Device Sequence Number: 2973740
• Product Code: FMI
• UDI-Device Identifier: 30382903051879
• UDI-Public: 30382903051879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 305187
• Device Lot Number: 9030812
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/23/2019
• 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