MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 300912

Device Problem Protective Measures Problem (3015)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 the bd syringe luer-lok¿ tip was used with "perfalgan (preventive premedication in the context of immunoglobulin infusion)" to treat a child who arrived in the pediatric emergency department.A syringe pump assigned to the patient "triggered downstream occlusion alarms during infusion and stopped", but no occlusion was observed on the line connected to the patient.This event has reportedly occurred since the "summer of 2018", and "appears at flow rates of d = 30 ml / h with bd plastipak 20 ml syringes".Currently, when the volume of medication to be administered is "between 11 and 20 ml", the volume is transferred into a "50 ml syringe" from the "20 ml syringe" using a connector.Pumps that issues occur with are reportedly "fresenius dps and fresenius agilia", which are regularly maintained with the occlusion alarm set to "300mmhg by default".The following information was provided by the initial reporter, translated from french to english: "4 children (from the same nursery) arrived at the pediatric emergency department and were treated at the same time with intravenous perfalgan (preventive premedication in the context of immunoglobulin infusion).A syringe pump was assigned to each patient, that is to say that 4 syringe pumps were used simultaneously.All 4 devices triggered downstream occlusion alarms during infusion and stopped (normal operation in case of non-compliant pressure sensing).Additional information from account manager in attached e-mails after follow-up visit to customer: i went to customer today (tuesday (b)(6) 2019) to observe issue, discuss it and get back samples.Mr.[.], nurse pediatric urgencies, came into mrs [.] office to explain us the issue.Since summer 2018, they are experiencing the same issue with bd plastipak 10ml (300912) and bd plastipak 20ml (300629).The issue seems not being with bd plastipak 50ml.They have identified this issue with lots with production date from may 2018.Last lots identified are 1808237 and 8276910.They do not remember having been facing this issue earlier in time.Issue happens with the following syringe pumps: fresenius dps and fresenius agilia.Both are regularly maintained and both have an occlusion alarm set on 300mmhg by default.Pumps only have bd plastipak turned on.Mr [.] and his colleagues have been investigating by perfalgan provider (because the issue happened mainly with this medicine in ped/neo) and by line provider.They also investigated the peripheric vein catheter¿ none of these had any changes in the past¿ they then tried an ¿empty¿ syringe on the pump and were able to reproduce the issue.Today, mr [.] showed me on a dps with an empty plastipak 20ml, with a rate @ 40ml/h.The occlusion alarm happened after <2min.As you can see on the video, the occlusion went high pretty quick.He confirmed me having tested with different medicine, nacl and empty syringes and was able to reproduce it.I have tested the same syringe used today with an alaris pk pls (s/n (b)(4)).We can clearly see that there is some resistance, despite syringe is empty and connected to no line, neither patient and i was able to reproduce the occlusion alarm with a rate @30ml/h.Also when manipulating the plungers by hand, mr.[.] and mrs [.] both mentioned that the plunger was pretty difficult to move and were asking about the silicon.Please make sure that this email is forwarded connected to the complaint, as this is the second one since last (b)(6).".

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.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.

Event Description

It was reported that the bd syringe luer-lok¿ tip was used with "perfalgan (preventive premedication in the context of immunoglobulin infusion)" to treat a child who arrived in the pediatric emergency department.A syringe pump assigned to the patient "triggered downstream occlusion alarms during infusion and stopped", but no occlusion was observed on the line connected to the patient.This event has reportedly occurred since the "summer of 2018", and "appears at flow rates of d 30 ml / h with bd plastipak 20 ml syringes".Currently, when the volume of medication to be administered is "between 11 and 20 ml", the volume is transferred into a "50 ml syringe" from the "20 ml syringe" using a connector.Pumps that issues occur with are reportedly "fresenius dps and fresenius agilia", which are regularly maintained with the occlusion alarm set to "300mmhg by default".The following information was provided by the initial reporter, translated from french to english: "4 children (from the same nursery) arrived at the pediatric emergency department and were treated at the same time with intravenous perfalgan (preventive premedication in the context of immunoglobulin infusion).A syringe pump was assigned to each patient, that is to say that 4 syringe pumps were used simultaneously.All 4 devices triggered downstream occlusion alarms during infusion and stopped (normal operation in case of non-compliant pressure sensing)."additional" information from account manager in attached e-mails after follow-up visit to customer : i went to customer today (tuesday (b)(6) 2019) to observe issue, discuss it and get back samples.Mr., nurse pediatric urgencies, came into mrs office to explain us the issue.Since summer 2018, they are experiencing the same issue with bd plastipak 10ml (300912) and bd plastipak 20ml (300629).The issue seems not being with bd plastipak 50ml.They have identified this issue with lots with production date from may 2018.Last lots identified are 1808237 and 8276910.They do not remember having been facing this issue earlier in time.Issue happens with the following syringe pumps: fresenius dps and fresenius agilia.Both are regularly maintained and both have an occlusion alarm set on 300mmhg by default.Pumps only have bd plastipak turned on.Mr and his colleagues have been investigating by perfalgan provider (because the issue happened mainly with this medicine in ped/neo) and by line provider.They also investigated the peripheric vein catheter none of these had any changes in the past¿ they then tried an ¿empty¿ syringe on the pump and were able to reproduce the issue.Today, mr showed me on a dps with an empty plastipak 20ml, with a rate @ 40ml/h.The occlusion alarm happened after 2min.As you can see on the video, the occlusion went high pretty quick.He confirmed me having tested with different medicine, nacl and empty syringes and was able to reproduce it.I have tested the same syringe used today with an alaris pk pls (b)(4).We can clearly see that there is some resistance, despite syringe is empty and connected to no line, neither patient (see picture) and i was able to reproduce the occlusion alarm with a rate @30ml/h.Also when manipulating the plungers by hand, mr.And mrs both mentioned that the plunger was pretty difficult to move and were asking about the silicon.Please make sure that this email is forwarded connected to the complaint, as this is the second one since last (b)(6).".

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8453241
• MDR Text Key: 146504669
• Report Number: 1213809-2019-00378
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 300912
• Device Lot Number: 8276910
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other