MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 30 G X 7/8 IN BD¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 301664

Device Problems Defective Component (2292); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that foreign matter and defective labels were found on and/or in 30 g x 7/8 in bd¿ needle(s), before use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: samples were received in the (b)(4) plant for evaluation.The following result were obtained: 4 out of 8 bags found with loose black foreign material inside of bags in contact with product.No samples or photos were returned.Defect cannot be confirmed.1 bag missing required identification label.No samples or photos were returned.Defect cannot be confirmed.9 pieces found with black foreign material inside hubs.Two samples were found to have black fm in the id of the hub > level 3.(0.65% aql for fm - acc 5 / rej 6 on 315 pc.Sample).16 pieces found with black foreign material outside of hub.No black fm was found.One needle had a dark fiber on the hub, and one had an epoxy dripover.(0.65% aql for fm - acc 5 / rej 6 on 315 pc.Sample).Samples were sent for ftir analysis, but it was deemed that the samples were too small to test.A dhr was completed with zero defects found.Investigation conclusion: root cause is undetermined.Long term corrective action: not applicable - samples do not fail specification.

• Brand Name: 30 G X 7/8 IN BD¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7154835
• MDR Text Key: 96223478
• Report Number: 1911916-2017-00378
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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
• Device Operator: Other
• Device Catalogue Number: 301664
• Device Lot Number: 7136623
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other