MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Medical 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 the bd posiflush¿ sp was missing its label before use.The following information was provided by the initial reporter: "the pharmacist assistant found this sp syringe without tag, name or lot number.".

Event Description

It was reported that the bd posiflush¿ sp was missing its label before use.The following information was provided by the initial reporter: "the farmacist assistant found this sp syringe without tag, name or lot number.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 10/15/2020 h.6.Investigation: a device history record review was not able to be completed, as the batch number for this complaint was unknown.To aid in the investigation of this incident, 1 picture and 1 physical sample was received for evaluation by our quality team.Through examination of the physical sample, one 10ml syringe is shown with no syringe barrel label.The photo shows a 10ml syringe with no barrel label.The cause for this defect could have resulted from the plunger rod labeler machine, where it had a stop-start cycle and missed assembling the barrel label and went undetected.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10688039
• MDR Text Key: 214801948
• Report Number: 2243072-2020-01660
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other