MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number	309654
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe tip of the 10 ml bd posiflush¿ normal saline syringe was ¿deformed¿, before use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no related issues or defects found in dhr.No related quality notifications were issued to this batch number.Sample and photo were provided with a bent syringe tip.Investigation conclusion: root cause is unknown.Damage could have potentially happened from a machine jam in the assembly process, but based off the sample and dhr review ¿ no true root cause could be determined.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7169099
• Report Number: 1911916-2017-00398
• Device Sequence Number: 16373035
• Product Code: FMF
• UDI-Device Identifier: 00382903096541
• UDI-Public: 00382903096541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: Nurse
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 309654
• Device Lot Number: 6354960
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/07/2018
• 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