MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ 4% SODIUM CITRATE FILL

Catalog Number 303270

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no photos or samples were received for evaluation.Lot#7214572 3ml citrate catalog# 303270 was produced on 8/08/2017.The claimed mixed syringe catalog# 306423, lot#606777n (note the complaint doesn¿t include the letter n) was produced on 3/07/2016; 17 months earlier.Our automated process includes line clearance between each batch.Complaints records were reviewed from fy14 to date; finding zero complaints for mixed batches/ products (this includes saline 20 different catalog#s, heparin 4 different catalog#s and citrate 2 different catalog#s ).Investigation conclusion: this is the first complaint for the lot# 7214572 for the same defect or symptom.There was no documentation of issues for the complaint of batch 7214572 during this production run.Root cause description: undetermined.

Event Description

It was reported that a box of bd posiflush¿ 4% sodium citrate fill had mixed products.One, 100u/ml heparin syringe was found mixed in the box.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that a box of bd posiflush 4% sodium citrate fill had mixed products.One, 100u/ml heparin syringe was found mixed in the box.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Over 250 line clearance were performed between the heparin batch 606777n and the citrate batch 7214572.Bd does a 100% inspection; we have a camera to inspect the tip color.(heparin= yellow, citrate= green).For batch change saline to heparin, heparin to saline, heparin to citrate, etc., we do a camera challenge.The packaging is an automated process, right after the 100% tip cap color verification.

Event Description

It was reported that a box of bd posiflush 4% sodium citrate fill had mixed products.One, 100u/ml heparin syringe was found mixed in the box.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 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: no.

• Brand Name: BD POSIFLUSH¿ 4% SODIUM CITRATE FILL
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7774325
• MDR Text Key: 117008767
• Report Number: 1911916-2018-00441
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/08/2018
• Device Catalogue Number: 303270
• Device Lot Number: 7214572
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 07/19/2018; 07/19/2018
• Supplement Dates FDA Received: 09/11/2018; 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other