MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306544
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).Device evaluated by mfr: 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¿ normal saline syringe pump is not giving the correct volume.This was discovered during use.The following information was provided by the initial reporter: material no: 306544, batch no: unknown.It was reported that the pump is unable to detect the syringes and is not delivering the correct volume.Description of problem: these 3ml ns flushes (larger barrel than the previous 3ml ns flushes, which were long and skinny) are not recognized by our alaris iv pumps correctly, instead of detecting a 3ml syringe, the pump only detects it as a 10ml syringe.When these new flushes were placed in our store room, rns were instructed to just run it as a 10cc flush.If this is selected, the pump is unable to deliver the desired volume of flush to the patient (ie: enter to flush 1ml, only.6 is delivered).This negatively impacts our patients, especially the smallest babies.If the whole flush isn't delivered, then medication is still in the iv line and the patient does not receive their entire dose.Some nurses- myself included- are working around this issue by using the sterile 10cc ns flushes that the pumps recognize and deliver the correct volume, but cost more.This has been an ongoing issue since the product was replaced.
Event or Problem Description
It was reported that bd posiflush¿ normal saline syringe pump is not giving the correct volume.This was discovered during use.The following information was provided by the initial reporter: material no: 306544 batch no: unknown it was reported that the pump is unable to detect the syringes and is not delivering the correct volume.Description of problem: these 3ml ns flushes (larger barrel than the previous 3ml ns flushes, which were long and skinny) are not recognized by our alaris iv pumps correctly, instead of detecting a 3ml syringe, the pump only detects it as a 10ml syringe.When these new flushes were placed in our store room, rns were instructed to just run it as a 10cc flush.If this is selected, the pump is unable to deliver the desired volume of flush to the patient (ie: enter to flush 1ml, only.6 is delivered).This negatively impacts our patients, especially the smallest babies.If the whole flush isn't delivered, then medication is still in the iv line and the patient does not receive their entire dose.Some nurses- myself included- are working around this issue by using the sterile 10cc ns flushes that the pumps recognize and deliver the correct volume, but cost more.This has been an ongoing issue since the product was replaced.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8800270
• Report Number: 1911916-2019-00716
• Device Sequence Number: 10877054
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: Health Professional
• Device Catalogue Number: 306544
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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