MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 10ml reg pr saline 10ml fill saline was hard to discharge.The following information was provided by the initial reporter: material no.306546 batch no.0227075.It was reported that it is very hard to discharge the saline.Verbatim: per customer's response (b)(6) 2021.What is the date of event? (b)(6) 2021.Was anyone hurt? no.How many syringes were involved? 1 syringe kept.Told this has happened a few times.Do you have sample available, if so please find return (b)(6) prepaid label to return sample for evaluation.The sample i have has been discharged but you can have it for review.Hi, i have received a complaint about item 306546 some are very hard to discharge the saline.I experienced this issue using lot number 0227075 but could not recreate the issue.The flush was extremely hard to push in to the point where nursing had to remove and use a different setup.

Manufacturer Narrative

H6: investigation summary.A device history record review was completed for provided lot number 0227075.The review did reveal one related non-conformance during the production process that could have potentially contributed to this incident.During the production process an intermittent issue related to dry barrels was detected.The issue was resolved at the time of occurrence and all product associated with the defect was held for inspection with the affected material scrapped.As a sample was unavailable for return, a thorough sample investigation could not be completed.

Event Description

It was reported that syringe 10ml reg pr saline 10ml fill saline was hard to discharge.The following information was provided by the initial reporter: material no.306546, batch no.0227075.It was reported that it is very hard to discharge the saline.Verbatim: per customer's response 02/04/2021.What is the date of event? (b)(6) 2021.Was anyone hurt? no.How many syringes were involved? 1 syringe kept.Told this has happened a few times.Do you have sample available, if so please find attached return fedex prepaid label to return sample for evaluation.The sample i have has been discharged but you can have it for review.Hi.I have received a complaint about item 306546 some are very hard to discharge the saline.I experienced this issue using lot number 0227075 but could not recreate the issue.The flush was extremely hard to push in to the point where nursing had to remove and use a different setup.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11381675
• MDR Text Key: 241752921
• Report Number: 9616657-2021-00026
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 306546
• Device Lot Number: 0227075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1