MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ VIALON E IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 388412

Device Problem Break (1069)

Patient Problems Skin Tears (2516); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd insyte¿ vialon e iv catheter experienced the catheter breaking from the hub.The following information was provided by the initial reporter: the hcp tried to remove the indwelling catheter and felt resistance with a breaking-like sound.When checking the removed catheter, the hcp found it shorter and a broken piece remained into the body.

Manufacturer Narrative

Per additional information received, the following information has been updated: b.1 adverse event and/or product problem: reported issue is both an adverse event, and a product problem.B.5 describe event or problem: it was reported that the bd insyte¿ vialon e iv catheter experienced the catheter breaking from the hub.The broken portion of the catheter was removed surgically.The following information was provided by the initial reporter: the hcp tried to remove the indwelling catheter and felt resistance with a breaking-like sound.When checking the removed catheter, the hcp found it shorter and a broken piece remained into the body.Broken end of catheter was removed surgically b.6 relevant tests/laboratory data: the broken portion of the catheter was removed surgically.H.1 type of reportable event: serious injury.H.6 imdrf annex e grid: e1721: skin tears.H.6 imdrf annex f grid: f1901: additional surgery.H3 other text : see h10.

Event Description

It was reported that the bd insyte¿ vialon e iv catheter experienced the catheter breaking from the hub.The broken portion of the catheter was removed surgically.The following information was provided by the initial reporter: the hcp tried to remove the indwelling catheter and felt resistance with a breaking-like sound.When checking the removed catheter, the hcp found it shorter and a broken piece remained into the body.Broken end of catheter was removed surgically.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 12-oct-2022 h6: investigation summary eight photos and one sample were received by our quality team for evaluation.From the photos, the catheter tubing was observed to be broken off into two fragments near the catheter tip.At the breakage point, the first fragment nearest to the catheter tip has a clean slanted cut, whereas the second fragment has a jagged cut on the other end.The sample was subjected to visual inspection to check for catheter damage.The catheter tubing was observed to be broken off into two fragments near the catheter tip.At the breakage point, the first fragment with the catheter tip has a clean slanted cut, whereas the second fragment has a jagged cut on the other end.A cut was observed on the catheter tubing remaining on the adapter.A device history record could not be evaluated as the lot number is unknown.The assembly process was reviewed, the only station that is in contact with the catheter tubing is the rubber pads at the flaring station.Given the elastic nature of the rubber pads wand that there are no sharp or hard edges on the pads, this station is unlikely to cause the observed slanted or jagged cut on the catheter tubing.As the sample was used, the cuts could have occurred during product application.Based on the verbatim, ¿after confirming backflow¿, there was blood flashback being observed during insertion, therefore the cannula was not occluded.Current quality controls for catheter damage include a daily outgoing functional test and start-of-shift in-process functional test in place to check for catheter to adapter pull force.There is also a daily outgoing visual inspection and in-process visual inspection in place to check for catheter damage.Current quality controls for cannula occlusion include a daily outgoing functional test in place to check flashback time to detect cannula occlusion.As the returned sample was used, the actual root cause cannot be established.

Event Description

It was reported that the bd insyte¿ vialon e iv catheter experienced the catheter breaking from the hub.The broken portion of the catheter was removed surgically.The following information was provided by the initial reporter: the hcp tried to remove the indwelling catheter and felt resistance with a breaking-like sound.When checking the removed catheter, the hcp found it shorter and a broken piece remained into the body.Broken end of catheter was removed surgically.

• Brand Name: BD INSYTE¿ VIALON E IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15635879
• MDR Text Key: 306686809
• Report Number: 8041187-2022-00601
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2022

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 Catalogue Number: 388412
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 10/19/2022; 11/18/2022
• Supplement Dates FDA Received: 10/27/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention