MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306546

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that sterile breach occurred before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "it was reported that when box was opened, several caps on the syringes are flat and dirty.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported that sterile breach occurred before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "it was reported that when box was opened, several caps on the syringes are flat and dirty.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8940074
• MDR Text Key: 155982880
• Report Number: 1911916-2019-00870
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 306546
• Device Lot Number: 9107938
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other