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

Catalog Number 306413

Device Problem Packaging Problem (3007)

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

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: on (b)(6) 2018 two (2) samples were received.They are in the sealed packaging flow wrap.Both have the plunger rod-rubber stopper, the tip cap and saline solution.Both have the barrel label missing.Product within specification? there were no documented issues for the complaint of batch (b)(4) during this production run.All the inspections performed while manufacturing this batch were accepted; no rejections were documented.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no issues documented about labeling.Capa not required for this event.

Event Description

It was reported that a package of bd¿ heparin syringe(s) were received without labels, barcodes or expirations labels.The syringes were not used and there was no report of serious injury or medical interventions.

• Brand Name: BD¿ HEPARIN SYRINGE
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7526556
• MDR Text Key: 108998296
• Report Number: 1911916-2018-00233
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 306413
• Device Lot Number: 727191N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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
• Patient Outcome(s): Other