MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306424

Device Problems Contamination (1120); Material Opacification (1426)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: three samples were received.They have sealed packaging flow wrap, the plunger rod-rubber stopper, the tip cap.The barrel labels show the lot#811686n.The batch records for lot# 811686n were reviewed finding no documentation of issues for the complaint during this production run.Visual inspection of the three (3) samples was performed finding no discoloration/ variation of color nor cloudy.The lab performed testing for appearance and solution clarity and endotoxin.Results show products passed.This product has a barrel label with a section of yellow color as well as yellow tip cap, it is possible the reflection of the yellow color has induced the concerns expressed by the customer.This is the first complaint for the lot# 807864n for the same defect or symptom.There was no documentation of issues for the complaint of batch 807864n during this production run.Root cause description: undetermined.Rationale: capa not necessary.

Event Description

It was reported that the barrel of the bd posiflush¿ heparin lock flush syringe was opaque, making it impossible to determine if the heparin inside was clear or cloudy.This made the user extremely uncomfortable using these syringes due to the possibility of injecting contaminated fluid into the patient.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

Event Description

It was reported that the barrel of the bd posiflush¿ heparin lock flush syringe was opaque, making it impossible to determine if the heparin inside was clear or cloudy.This made the user extremely uncomfortable using these syringes due to the possibility of injecting contaminated fluid into the patient.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7736859
• MDR Text Key: 115773103
• Report Number: 1911916-2018-00417
• Device Sequence Number: 0
• Product Code: NZW
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 306424
• Device Lot Number: 807864N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other