MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 30GA 7/8IN BSG CLEAR HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	302890
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7137558.Medical device expiration date: n/a.Device manufacture date: 2017-05-17.Medical device lot #: 8145979.Medical device expiration date: n/a.Device manufacture date: 2018-05-25.Medical device lot #: 7054534.Medical device expiration date: n/a.Device manufacture date: 2017-02-23.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 needle 30ga 7/8 in bsg clear hub was occluded and the needle separated from the syringe.This was discovered during use.The following information was provided by the initial reporter: material no.302890, batch no.Unknown (provided 7137558 , 8145979, and 7054534, stated this needle was from one of the three lots provided).It was reported the cannula is occluded and the cannula shot off the syringe.Nature of incident: cannula is occluded, cannula shot off the syringe evaluation: 1 sample was returned to bvi and product was tested per current process flow test and it failed, also tested with water and its occluded, when looked thru microscope it was possible to observe that between the end of the hub and the beginning of the needle there is something (not clear of what this is) but it looks like adhesive that is obstructing the flow thru the needle.
Additional Manufacturer Narrative
H.6.Investigation summary: one (1) sample and two (2) photos were provided by the customer for investigation.He sample was returned unshielded but in a protective case with a sharp bend in the needle which made the needle not able to be tested by bd.Two (2) photos were also provided by the customer for investigation.The first photo shows the inside of the needle hub viewed with low magnification.There is a dark circle where the needle would be located.The second photo shows a closer view of the needle and it appears that there might be a clog present.The customer reported that the sample was tested with water at their facility and that it failed indicating that the sample was clogged.Foreign material (fm) can be introduced to the fluid path during the manufacturing process which could cause the needle to become clogged.All product is automatically checked for clogged needles during the production process.A device history record (dhr) review was performed on the batches associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Bd acknowledges that the returned needle was clogged.However, as this one (1) occurrence would not exceed the acceptable quality level (aql) for the batch no corrective or preventative actions are proposed in the scope of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that needle 30ga 7/8in bsg clear hub was occluded and the needle separated from the syringe.This was discovered during use.The following information was provided by the initial reporter: material no.302890; batch no.Unknown (provided 7137558, 8145979, and 7054534, stated this needle was from one of the three lots provided).It was reported the cannula is occluded and the cannula shot off the syringe.Nature of incident: cannula is occluded, cannula shot off the syringe evaluation: 1 sample was returned to bvi and product was tested per current process flow test and it failed, also tested with water and its occluded, when looked thru microscope it was possible to observe that between the end of the hub and the beginning of the needle there is something (not clear of what this is) but it looks like adhesive that is obstructing the flow thru the needle.

• Brand Name: NEEDLE 30GA 7/8IN BSG CLEAR HUB
• 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: 8935156
• Report Number: 1911916-2019-00866
• Device Sequence Number: 329012
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: 50382903028905
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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 Catalogue Number: 302890
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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