MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 27GA 7/8IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	302891
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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 is reported that there was a mix of product, foreign matter on device, and 7 occasions of double needles with a bd needle 27ga 7/8in.This was discovered prior to use.The following information was provided by the initial reporter: it was reported a needle was found with an orange hub, a needle was found with an unknown part on top, and 7 needles were found with a double needle.Additional information received by customer: inside bag an orange hub was found( part on right side).Inside bag a gray cannula received with an unknown part on top (part on left), double needle assemble into cannula.A total of 7 pieces 7 were reported but on 4 samples with the extra needle fall off and second needle was not recovered.
Additional Manufacturer Narrative
Investigation: nine samples were received.They came in two separate plastic bags.In one plastic bag there are two parts; one with orange hub and the other one with gray hub.The other plastic bag has four parts with double needle, one with silicone drip over the plastic hub and two that no defect was noticed.The different color hub is related to handling of material during the assembly process.A mis-assembly at the cannulation operation causes a double cannula.A needle misses the hub, and falls on to the adjacent needle on the rack.If the operator does not see it, the epoxy cures, and the second cannula sticks to the assembled needle.The dvt camera that inspects for epoxy may catch this defect if the defect is on the side facing the camera.It is essentially the responsibility of the assembly associate to monitor for these defects, correct the issue, and remove the affected needles.An epoxy drip over generally occurs when the epoxy applicator fails to shut off for a missing cannula.There are several contributing / possible factors.A dirty sensor that doesn¿t shut the epoxy off for a missing cannula the epoxy pressure is too high.The epoxy applicator needs attention ¿ it isn¿t shutting off when it should.The epoxy viscosity is also related to temperature fluctuations.If the temperature goes up, the epoxy gets thinner and flows faster.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It is reported that there was a mix of product, foreign matter on device, and 7 occasions of double needles with a bd needle 27ga 7/8in.This was discovered prior to use.The following information was provided by the initial reporter: it was reported a needle was found with an orange hub, a needle was found with an unknown part on top, and 7 needles were found with a double needle.Additional information received by customer: inside bag an orange hub was found( part on right side) inside bag a gray cannula received with an unknown part on top (part on left), double needle assemble into cannula.A total of 7 pieces 7 were reported but on 4 samples with the extra needle fall off and second needle was not recovered.

• Brand Name: BD NEEDLE 27GA 7/8IN
• 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: 9310771
• Report Number: 1911916-2019-01195
• Device Sequence Number: 19581559
• Product Code: FMI
• UDI-Device Identifier: 50382903028912
• UDI-Public: 50382903028912
• 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): 12/04/2019

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: 302891
• Device Lot Number: 9144721
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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