MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Positioning Failure (1158)

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

Event Date 10/05/2021

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.

Event Description

It was reported that bd posiflush¿ 10ml syringe saline flush cap was deformed.The following information was provided by the initial reporter: the customer complained that the white cap was found deformed and had some dirt on it.

Event Description

It was reported that bd posiflush¿ 10ml syringe saline flush cap was deformed.The following information was provided by the initial reporter: the customer complained that the white cap was found deformed and had some dirt on it.

Manufacturer Narrative

H6: investigation summary: it was reported the white cap was found deformed and had some dirt on it.To aid in the investigation, one sample with no packaging flow wrap and two photos were provided for evaluation by our quality team.A visual inspection was performed.The tip cap of the sample is damaged and has spots with discoloration.No other defects or imperfections were observed.The two photos provided show the sample received.This defect could occur if the syringe was not properly placed in the sterilization tray inducing the damage and discoloration.A device history record review was completed for provided material number 306546, lot number 1082924.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the sterilization tray loading process was performed.The settings were correct and the parts were being placed correctly.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12747322
• MDR Text Key: 280092770
• Report Number: 1911916-2021-01133
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K161552
• 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: 11/08/2021

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 306546
• Device Lot Number: 1082924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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