MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLES; 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	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6) has been used as a default.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 bd precisionglide¿ needles came with a mix of product types.This was discovered before use.The following information was provided by the initial reporter: material no.: 305187 batch no.: 9030182.It was reported that two different needles were received in the same line of product with serrated tear lines.Reporter stated that 2 needles were found in same package.She said that she can email us with photos and more details.Reporter said that it was noticed "late yesterday" ((b)(6) 2019).Per related email: needles packaged in the same line of product with serrated tear lines.One has a black hub color and is shorter with a smaller gauge needle.The other had a brown hub and is longer with a larger gauge.
Event or Problem Description
It was reported that bd precisionglide¿ needles came with a mix of product types.This was discovered before use.The following information was provided by the initial reporter: material no.: 305187, batch no.: 9030182.It was reported that two different needles were received in the same line of product with serrated tear lines.Reporter stated that 2 needles were found in same package.She said that she can email us with photos and more details.Reporter said that it was noticed "late yesterday" (10/23/19).Per related email: needles packaged in the same line of product with serrated tear lines.One has a black hub color and is shorter with a smaller gauge needle.The other had a brown hub and is longer with a larger gauge.
Additional Manufacturer Narrative
H.6.Investigation summary: two (2) photos were provided by the customer.One (1) photo shows the top web of two (2) blister packs providing the product number and description.The blister packs are still connected showing that they were packaged this way.The second (2nd) photo shows two (2) blister packs viewed from the bottom web.The needle hubs and needle lengths appear to be different indicating that there are two (2) different products packaged together as blister packs are still connected showing that they were packaged this way.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.On 31-oct-2019 a global hold was issued to material # 305187 lot #9030812 to contain this batch.H3 other text : see section h.10.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9295706
• Report Number: 1911916-2019-01169
• Device Sequence Number: 16727977
• Product Code: FMI
• UDI-Device Identifier: 30382903051879
• UDI-Public: 30382903051879
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 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: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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