MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACTIVATED SPLIT SEPTUM; Q-SYTE/ SPLIT SEPTUM

Catalog Number 395242

Device Problems Leak/Splash (1354); Split (2537)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 q-syte¿ luer activated split septum leaked from the septum during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Device/batch history record could not be evaluated as the lot number is unknown.Observations and testing: received a stopcock valve attached to an extension set.The valve had a q-syte (top only) attached (bonded).Visual/microscopic evaluation: the septum was of 16 mold cavity.Severe damage (tear) was observed on the slit or the top disk.The top septum disk was unglued from the rim of the q-syte residual septum material and adhesive was observed on the rim of the top body.Damage (tear) was observed on the column wall damage (tear) was observed on the bottom disk slit (unit was disassembled after water/leak test).Water leak test (mm-110): attached the iso standard luer from the water leak test to the end of the ext.Set where the q-syte unit was bonded, no leakage was observed on the un-actuated position.Leakage was observed when the unit was tested in the actuated position, the source of the leakage was the tear on the top of the septum.Damage was observed on the slit of the septum top, bottom and column wall and the unit leaked when it was tested in the actuated position, the source of the leakage was the tear on the top of the septum.Root cause for this incident is indeterminate.A definite source that contributed to the tears (top-bottom slits and column wall) could not be established.The damage is normally attributed to incorrect usage or excessive actuations.An instruction pamphlet is provided with q-syte product.This information documents the potential failure modes of this device if not used properly.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD Q-SYTE¿ LUER ACTIVATED SPLIT SEPTUM
• Type of Device: Q-SYTE/ SPLIT SEPTUM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7360385
• MDR Text Key: 103291565
• Report Number: 9610847-2018-00074
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395242
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other