MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k161552 ((b)(6)), pma / 510(k)#: k141311 ((b)(6)).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 2 bd posiflush¿ normal saline syringes "squirted" saline solution onto the staff during use while flushing their lines.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "saline solution squirted out of the back of syringe as they were flushing a line.".

Event Description

It was reported that 2 bd posiflush¿ normal saline syringes "squirted" saline solution onto the staff during use while flushing their lines.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "saline solution squirted out of the back of syringe as they were flushing a line.".

Manufacturer Narrative

H.6.Investigation summary: a bd quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.H3 other text : see section h.10.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8832064
• MDR Text Key: 159630052
• Report Number: 9616657-2019-00273
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10.
• 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: 08/23/2019

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: 02/28/2022
• Device Catalogue Number: 306546
• Device Lot Number: 9065683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other