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

Catalog Number	306413
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7526556
• Report Number: 1911916-2018-00233
• Device Sequence Number: 19245508
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: UK
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other