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

Catalog Number 381312

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(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 insyte-w ¿ iv catheter had needle through catheter before use.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported that the bd insyte-w iv catheter had needle through catheter before use.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: one actual sample in opened packaging was returned for investigation.The actual sample was subjected to visual inspection.Cannula pierced through catheter was observed on the returned sample.The nonconformance sample was challenged at the automated vision inspection system.The system was able to reject the nonconformance and the sample was sent into the reject bin.Device history record of packaged needle batch 7324308, catalogue number 381312 and its assembled needle batches 7293498 and 7324341, catalogue number 8083540 was reviewed.No quality notification was raised for similar nonconformance during the production of this batch.The preventive maintenance, calibration and equipment history records were reviewed.No abnormality was observed on the records.The nonconformance could have occurred during assembly of catheter and cannula or during product application when the product was manipulated.However, there is an automated vision inspection machine, which can detect and reject product with cannula pierced through catheter in the assembly process.Hence, the root cause of the nonconformance could not be determined.The trend of this nonconformance will be monitored.

Event Description

It was reported that the bd insyte-w ¿ iv catheter had needle through catheter before use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSYTE-W ¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7698992
• MDR Text Key: 114422773
• Report Number: 8041187-2018-00239
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813125
• UDI-Public: 30382903813125
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 381312
• Device Lot Number: 7324308
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other