MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE FLUSH

Catalog Number 306553

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 01/31/2018

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 a 10 ml bd posiflush¿ sf saline syringe was found protruding through the packaging breaking the sterile barrier.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: photo of the affected samples was received.The photo was visually evaluated and showed the reported defect.In the absence of a sample the root cause could not be assigned.The non-conformances were reviewed for this batch; there was no non-conformance associated with this defect.A significant amount of in process testing is performed during the manufacturing of each posiflush batch.This type of defect would be rejected at multiple stages during the manufacturing process.Bd would prefer to operate at zero tolerance for all potential issues within our manufacturing processes; however, occasional defects do occur.Investigation conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7290847
• MDR Text Key: 100925422
• Report Number: 9616657-2018-00003
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7319531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other