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	09/11/2019
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 occurred with a needle 19x1-1/2 rb tw.The following information was provided by the initial reporter, "we have a major issue with some bd needles ¿ size 19g x 1 ½ ref 305187.An entire pack of needles that were two different sizes in the pack.Same lot number: 9030812.".
Additional Manufacturer Narrative
H.6.Investigation summary: approximately one hundred fifty (150) samples and two (2) photos were provided by the customer for investigation.The samples were visually examined using unaided vision and it was observed that eighty (80) of the returned samples were needle hubs which were gray rather than brown.It was also noted that the needles in the gray hubs were shorter than the needles in the brown hubs.Two (2) photos were also provided by the customer for investigation.One (1) photo shows ten (10) samples in two (2) blister pack strips of five (5).Five (5) of the samples have gray needle hubs and five (5) of the samples have brown needle hubs.The gray and brown needle hubs are mixed between the two (2) blister pack strips indicating that the needle hubs were mixed when they were packaged.The second (2nd) photo shows two (2) blister packs.One (1) blister pack has a brown needle hub and the second (2nd) blister pack has a gray needle hub which has a needle which is shorter than the needle in the brown needle hub.The blister packs are connected indicating that the needle hubs were packaged this way.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.A review was conducted of the materials being produced around the same time as the batch associated with this complaint revealed that machinery 5 was producing 22 gauge needle hub assemblies, which are gray in color, at the same time as the batch associated with this complaint was being produced on machinery 6.Therefore, it is possible that an operator manually dumped the incorrect needle hub assemblies into a product hopper.Bd acknowledges that the returned samples contained mixed product.Bd quality and production associates are currently having brainstorming meetings to try and determine long-term preventative actions to reduce the possibility of this non-conformance in the future.Additionally, as a means of raising awareness to this issue a quality alert will be issued to all associates involved in the production of this material.This quality alert will be shared at shift startup meetings.H3 other text : see section h.10.
Event or Problem Description
It was reported that mixed product occurred with a needle 19x1-1/2 rb tw.The following information was provided by the initial reporter, "we have a major issue with some bd needles ¿ size 19g x 1 ½ ref 305187.An entire pack of needles that were two different sizes in the pack.Same lot number: 9030812.".

• 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: 9163849
• Report Number: 1911916-2019-01055
• Device Sequence Number: 19378997
• Product Code: FMI
• UDI-Device Identifier: 30382903051879
• UDI-Public: 30382903051879
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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