MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problems Break (1069); Volume Accuracy Problem (1675)

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

Event Date 02/14/2022

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 the barrel was damaged and the label was unreadable.The following information was provided by the initial reporter: tube broken and wrinkled label.

Event Description

It was reported while using bd posiflush¿ pre-filled saline syringe the barrel was damaged and the label was unreadable.The following information was provided by the initial reporter: tube broken and wrinkled label.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided material number 306574 and lot number 1187703.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.To aid in the investigation of this issue, picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, one syringe was observed with a wrinkled label, another syringe had a piece of broken barrel within the unit packaging, and another unit package was observed torn.The barrel piece found inside of the package was most likely a result of a jam in the syringe feeder; however, based on the pictures alone, it cannot be confirmed if the broken piece is from the syringe it is packaged with.The wrinkled label originated at the label dispenser due to an excess of glue.This is a label material defect and we are currently working with the supplier on this issue.The production plant has increased the frequency of the label dispenser cleaning in order to avoid this issue.In the case of severely sticky labels, the operators clean the dispenser every fifteen minutes.If the packaging length is cut too short, the tension applied at the areas of the tip carp or plunger may lead to film breakage.This type of defect may result if the unit packaging station is not well adjusted and the film is not centered.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13599511
• MDR Text Key: 286773420
• Report Number: 1911916-2022-00106
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306574
• Device Lot Number: 1187703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• 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