MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 386804

Device Problem Structural Problem (2506)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

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 when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, " paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that the first incident involved mr.Xxxx, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿? technique related, (b)(6) said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle.Did the needle stick occurr before, during or after use?- during use.Was there medical intervention? unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation? no".

Manufacturer Narrative

Describe event or problem: it was reported that when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that that the first incident, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿?- technique related, said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle did the needle stick occurr before, during or after use?- during use was there medical intervention?- unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation?- no.Investigation summary: no samples and photo were returned for investigation.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.The investigation was not able to confirm the what customer had experienced as no samples and no photos were received for evaluation.Hence, root cause is unable to be determined.

Event Description

It was reported that when using a bd cathena¿ safety iv catheter there was a needle stick.The following was reported, paramedic contacted me via text message on sunday, march 3rd to report two pirs.Conveyed that that the first incident, using a 20g cathena resulted in a needle stick due to "structural failure of the device." first incident the clear blood piece came free resulting in a needle stick.Sample was placed in a bio-hazardous bag but then accidentally thrown out.Will meet in person so gather additional info.Per customer information response: can you please explain what you mean by ¿structural failure device¿?- technique related, said ¿structural failure because he is was brought to our attention most of the er staff were ¿breaking¿ the needle did the needle stick occurr before, during or after use?- during use was there medical intervention?- unknown.Exposure to blood/bodily fluid?-unknown.Are samples available for evaluation?- no.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8437304
• MDR Text Key: 139413633
• Report Number: 8041187-2019-00240
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 382903868049
• 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: 04/26/2019

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: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 386804
• Device Lot Number: 8044068
• Initial Date Manufacturer Received: 03/03/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/03/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other