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

Model Number 306546

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter addr: (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 the 10 ml bd posiflush¿ normal saline syringe experienced a damaged tip cap.The following information was provided by the initial reporter: the customer complained that the tip and cap of the product was destroyed.

Event Description

It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced a damaged tip cap.The following information was provided by the initial reporter: the customer complained that the tip and cap of the product was destroyed.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/3/2021.H.6.Investigation: it was reported the tip cap of the product is destroyed.To aid in the investigation, one sample in a sealed packaging flow wrap and two photos were provided for evaluation by our quality team.The photos shows the tip cap damaged from excessive compression.A visual inspection was performed to the sample received and the tip cap is damaged; it is the sample shown in the photos.This defect can occur during the sterilization process.Parts are placed in trays to be sterilized and there are layers of trays that go one on top of another.The damage to this part could be induced when the syringe was not properly placed in the tray.When the next tray is placed on top, the tip cap could become damaged.A device history record review was completed for provided material number 306546, lot 0323265.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 high sensor and syringe placement was performed finding everything acceptable.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: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12178264
• MDR Text Key: 261951908
• Report Number: 1911916-2021-00685
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: 11/30/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0323265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1