MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).

Event Description

It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report # was sent in error.This device issue was caused by shipping incidents, not a manufacturing issue.As the problem was not caused by bd, cancelation has been requested for this complaint.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13592320
• MDR Text Key: 286070053
• Report Number: 3002682307-2022-00066
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306574
• Device Lot Number: 1187484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1