MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE I.V. CATHETER 22GA X 1.00IN (0.9 X 25 MM) (VIALON E); INTRAVASCULAR CATHETER

Catalog Number 388523

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd insyte¿ i.V.Catheter 22ga x 1.00in (0.9 x 25 mm) (vialon e) had a needle through the catheter.The following information was provided by the initial reporter: "during puncture, hcp felt resistance and was unable to insert the catheter.When withdrawing and checking the catheter tip, a bent tip with a burr was found.".

Event Description

It was reported that bd insyte¿ i.V.Catheter 22ga x 1.00in (0.9 x 25 mm) (vialon e) had a needle through the catheter.The following information was provided by the initial reporter: "during puncture, hcp felt resistance and was unable to insert the catheter.When withdrawing and checking the catheter tip, a bent tip with a burr was found.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/13/2020.H.6.Investigation: four photos and one sample was received by our quality team for evaluation.Based on the returned sample and photos, a damaged catheter was observed, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Catheter damage could have been caused by needle pierced through the catheter.Based on the investigation, this would have occurred during product application when the product was manipulated or during assembly of catheter.A project, capa#590840, has been completed to further address actions required to prevent this incident from occurring during the assembly of the catheter.H3 other text : see h.10.

• Brand Name: BD INSYTE I.V. CATHETER 22GA X 1.00IN (0.9 X 25 MM) (VIALON E)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10286946
• MDR Text Key: 200649210
• Report Number: 8041187-2020-00413
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 07/24/2020

1 Device was Involved in the Event

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 388523
• Device Lot Number: 9108911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other