MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE 10ML FILL; INTRAVASCULAR CATHETER

Catalog Number 306546

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that ten syringe 10ml reg pr saline 10ml fill experienced foreign matter contamination.The following information was included by the customer: material no.306546 batch no.8262641.It was reported that there was plastic on the insertion tip."10ml non-sterile saline flush syringe and noticed that insertion tip had jagged piece of plastic attached.".

Manufacturer Narrative

Investigation: complaint trending review of the lot for this issue reveals this is the first complaint.The non-conformance's were reviewed for this batch and there was no record of non-conformance associated with this batch.The sample received confirmed foreign matter on the luer lock of the syringe.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.It is possible that the foreign matter originates from the moulding process.The inspection and detection activities shall be reviewed to determine adequacy.Capa 733763 has been raised to track corrective and preventive actions associated with this complaint.

Event Description

It was reported that ten syringe 10ml reg pr saline 10ml fill experienced foreign matter contamination.The following information was included by the customer: material no.306546 batch no.8262641 it was reported that there was plastic on the insertion tip."10ml non-sterile saline flush syringe and noticed that insertion tip had jagged piece of plastic attached.".

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8456626
• MDR Text Key: 140148939
• Report Number: 9616657-2019-00160
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8262641
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other