MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED NORMAL SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306499
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd posiflush¿ pre-filled normal saline syringe pump would not infuse.This was discovered during use.The following information was provided by the initial reporter: material no: 306499 batch no: unknown.It was reported that pump kept alarming "occluded" and would not infuse.Complaint: when trying to infuse dexamethasone (diluted in 10cc flush) pump kept alarming "occluded" and would not infuse.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text: see h.10.
Event or Problem Description
It was reported that bd posiflush¿ pre-filled normal saline syringe pump would not infuse.This was discovered during use.The following information was provided by the initial reporter: material no: 306499 batch no: unknown.It was reported that pump kept alarming "occluded" and would not infuse.Complaint: when trying to infuse dexamethasone (diluted in 10cc flush) pump kept alarming "occluded" and would not infuse.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9186200
• Report Number: 1911916-2019-01078
• Device Sequence Number: 16878087
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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
• Operator of Device: Other
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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