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

Catalog Number 306547

Device Problem Difficult to Flush (1251)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that 32 of the bd posiflush¿ normal saline syringe pumps alarm during use of syringe.The following information was provided by the initial reporter: med fusion pumps alarming occlusion when infusing ns flushes but not on continuous meds or meds drawn up by pharmacy.Pumps are set to high- least sensitive occlusion limits with intermittent meds, while continuous meds are set on low occlusion limits.Nnp's in to assess pt's single lumen picc line at the end of night shift which was patent.Other nurse in nursery experiencing the same thing with their meds.After troubleshooting all connections in line and line change done, continued to experience occlusions.While watching pressure bar on pump, i decided to twist the syringe plunger while med still infusing, and the pressure would then decrease.Continued to monitor throughout med infusion and twisting with no further occlusions.Drew flush up in 3ml syringe and infused without any increase in pressure.Did note that the plunger on the ns flushes have more resistance when pull back on it and after it sits.Product placed in xxx mailbox.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

(b)(4).Follow up.On november 16, 2023, bd issued a product advisory for the bd posiflush saline syringe with general pump compatibility.Through customer complaints, bd confirmed that an incorrect stopper was used in nine lots of 10ml bd posiflush¿ normal saline flush syringes with general pump compatibility.The use of bd posiflush prefilled flush syringes, catalog number 306547, with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.The product has been validated and is acceptable for manual use per ifu (instructions for use).Bd has identified a root cause and initiated corrective actions to prevent recurrence of this issue.Please see the attached product advisory and follow the actions required.If you need any further assistance, please contact the north american regional complaint center.A device history record review was completed by our quality engineer team for provided material number 306547 and lot numbers 3178284 and 3178299.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

No additional information received.Mat#: 306547.Batch#: 3226386 32 ea.3207555 30 ea.3178299 2 ea.3178284 2 ea.3714828 4 ea.It was reported by the customer that "med fusion pumps alarming occlusion when infusing ns flushes but not on continuous meds or meds drawn up by pharmacy.Pumps are set to high- least sensitive occlusion limits with intermittent meds, while continuous meds are set on low occlusion limits.Nnp's in to assess pt's single lumen picc line at the end of night shift which was patent.Other nurse in nursery experiencing the same thing with their meds.After troubleshooting all connections in line and line change done, continued to experience occlusions.While watching pressure bar on pump, i decided to twist the syringe plunger while med still infusing, and the pressure would then decrease.Continued to monitor throughout med infusion and twisting with no further occlusions.Drew flush up in 3ml syringe and infused without any increase in pressure.Did note that the plunger on the ns flushes have more resistance when pull back on it and after it sits.Product placed in xxx mailbox".Verbatim: good morning, we are having major issues with a certain lot at ummc west bank (lot# 3226386).We need this product investigated asap.They are wanting us to pull all product asap and it is everywhere.Can you put me in touch with the rep for these? we will need bd support to come to site to investigate right away and we will need product to replace the lot as well.Please let me know who can go out to west bank and how fast you could get product.Please see the issue below.Med fusion pumps alarming occlusion when infusing ns flushes but not on continuous meds or meds drawn up by pharmacy.Pumps are set to high- least sensitive occlusion limits with intermittent meds, while continuous meds are set on low occlusion limits.Nnp's in to assess pt's single lumen picc line at the end of night shift which was patent.Other nurse in nursery experiencing the same thing with their meds.After troubleshooting all connections in line and line change done, continued to experience occlusions.While watching pressure bar on pump, i decided to twist the syringe plunger while med still infusing, and the pressure would then decrease.Continued to monitor throughout med infusion and twisting with no further occlusions.Drew flush up in 3ml syringe and infused without any increase in pressure.Did note that the plunger on the ns flushes have more resistance when pull back on it and after it sits.Product placed in xxx mailbox.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17916724
• MDR Text Key: 325940056
• Report Number: 1911916-2023-00762
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: 3226386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1