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

Catalog Number	302890
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter: the customer's address is unknown:  (b)(6), usa has been used as a default.  device evaluated by mfr: 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 eleven needle 30ga 7/8in bsg clear hub experienced foreign matter contamination.The following information was provided by the initial reporter: material no.302890, batch no.8284657.It was reported needles had excess epoxy.Good morning, on (b)(6) 2019, while performing incoming inspection audit for bd part no.302890, lot no.8284657.With an inspection audit spec of aql 0.65 level ii it was found 11 parts with excess of epoxy, having these results it was decided to reject complete lot.Samples are available for your evaluation, so please help us to send the rma for the material describe below.Part no., lot no., boxes qty, qty per box, total, defect, supplier: 8029703, 8284657, 7, 20,000, 140,000, excess of epoxy, b-d.
Additional Manufacturer Narrative
H.6.Investigation: 14 samples were received.Eight samples have epoxy drip over on the plastic hub.The other six have no defects of any kind.Additionally, 4 photos were provided.They show the epoxy drip over on the plastic shield.Failure mode is verified.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 was reported that eleven needle 30ga 7/8in bsg clear hub experienced foreign matter contamination.The following information was provided by the initial reporter: material no.302890, batch no.8284657.It was reported needles had excess epoxy.Good morning, on (b)(6) 2019, while performing incoming inspection audit for bd part no.302890, lot no.8284657.With an inspection audit spec of aql 0.65 level ii it was found 11 parts with excess of epoxy , having these results it was decided to reject complete lot.Samples are available for your evaluation, so please help us to send the rma for the material describe below.Part no.: lot no.: boxes qty: qty per box: total: defect: supplier: 8029703, 8284657, 7, 20,000, (b)(4), excess of epoxy (b)(4).

• 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: 8509246
• Report Number: 1911916-2019-00375
• Device Sequence Number: 14142957
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: 50382903028905
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 8284657
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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