MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 1ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309628

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 4 bd 1ml syringe luer-lok¿ tips experienced foreign matter contamination.The following information was provided by the initial reporter: material no.: 309628 batch no.: unknown.Syringe 1ml luer-lok sterile, single.Use polycarbonate, bd#309628, 100 syringes/box.Our qc department has found that a few of them have a small drop of liquid in them.

Event Description

It was reported that 4 bd 1ml syringe luer-lok¿ tips experienced foreign matter contamination.The following information was provided by the initial reporter: material no.: 309628 , batch no.: unknown.Syringe 1ml luer-lok sterile, single.Use polycarbonate, bd#309628, 100 syringes/box.Our qc department has found that a few of them have a small drop of liquid in them.

Manufacturer Narrative

The following fields were updated due to additional information: b.3.Date of event: 12/2/2020.D.4.Medical device lot #: 9210923.D.4.Medical device expiration date: 7/31/2024.H.4.Device manufacture date: 9/13/2019.H.6.Investigation: one black and white photo of a loose 1ml syringe was received and evaluated.Due to the limited resolution of the photo, the "droplet of liquid" was unclear.Based on the verbatim the "droplet of liquid" was likely silicone.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD 1ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11103439
• MDR Text Key: 225130592
• Report Number: 1911916-2020-01162
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309628
• Device Lot Number: 9210923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1