MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: 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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.Investigation conclusion: bd was not able to duplicate or confirm the customers indicated failure as no sample, batch, or lot code was provided.Root cause description: since an investigation could not be performed bd was unable to determine a possible root cause.Rationale: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd intima-ii" closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, the patient was found leaking after the puncture of the indwentor needle was successfully injected with nutritional drugs at 9:00, the indwentor needle was immediately removed, the site was replaced and the puncture was performed again.The patient was explained to the patient and his family members, and no other adverse effects were caused to the patient.".

Manufacturer Narrative

H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.

Event Description

It was reported that the unspecified bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "on december 2, 2020, the patient was found leaking after the puncture of the indwentor needle was successfully injected with nutritional drugs at 9:00, the indwentor needle was immediately removed, the site was replaced and the puncture was performed again.The patient was explained to the patient and his family members, and no other adverse effects were caused to the patient.".

• Brand Name: UNSPECIFIED BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11103231
• MDR Text Key: 227072901
• Report Number: 2243072-2020-02259
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1