MAUDE Adverse Event Report: BECTON DICKINSON IV-SET V 180 CM PVC W/ PLUG RLS L-L; IV SET

Catalog Number 396370

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the iv-set v 180 cm pvc w/ plug rls l-l had inadequate amount of medicine delivered.Foreign complaint the following information was provided by the initial reporter: inadequate amount of medicine delivered.Test 1: material and method: 500 ml of nacl, r87 g 396370, measuring cup placed underneath, timing with stopwatch, 3 x performed, scale setting 250 ml / h.Results : device 1: after one hour 125 ml passed through after 2 only 250, device 2: 20 ml after 2 h, device 3: after 2 h 100 ml run through.Test 2: material and method, 500 ml of nacl, 03508079270 tutodrop device with scale, measuring cup placed underneath, timing with stopwatch, 3 x performed, scale setting 125 ml / h, 123/5000.Results : device 1: after 1 h only 125 ml passed through, device 2: empty after 1 h, device 3: after 1 h, run through 210 ml.

Manufacturer Narrative

H.6.Investigation summary: a lot number could not be connected to the device identified in the complaint so bd investigators could not conduct a device history review for this event.Additionally, a sample has not been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode.

Event Description

It was reported that the iv-set v 180 cm pvc w/ plug rls l-l had inadequate amount of medicine delivered.Foreign complaint the following information was provided by the initial reporter, translated from german to english: inadequate amount of medicine delivered.Test 1: material and method: 500 ml of nacl.R87 g 396370.Measuring cup placed underneath.Timing with stopwatch.3 x performed.Scale setting 250 ml / h.Results : device 1: after one hour 125 ml passed through after 2 only 250.Device 2: 20 ml after 2 h.Device 3: after 2 h 100 ml run through.Test 2: material and method.500 ml of nacl.03508079270 tutodrop device with scale.Measuring cup placed underneath.Timing with stopwatch.3 x performed.Scale setting 125 ml / h.123/5000.Results : device 1: after 1 h only 125 ml passed through.Device 2: empty after 1 h.Device 3: after 1 h, run through 210 ml.

• Brand Name: IV-SET V 180 CM PVC W/ PLUG RLS L-L
• Type of Device: IV SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8492964
• MDR Text Key: 147518491
• Report Number: 2243072-2019-00680
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 396370
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other