MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 18GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reds2515 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient had an ultrasound guided 18 gauge accucath iv placed into right upper arm.Once placed, it would not draw back or flush.It was correctly placed and verified with ultrasound.The iv was removed.Once removed, md tried to flush freely through the catheter and j loop.There was quite a bit of resistance and was also unable to draw back.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult infusion and inability to aspirate was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter.Light usage residues were observed and the extension set was attached to the luer adapter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, resistance was encountered.The sample was not patent to aspiration.Microscopic inspection of the sample revealed that the flow actuator was missing from the luer orifice.The missing flow actuator resulted in the blood control valve being closed, rather than held open as intended.It is unknown if the flow actuator was omitted during assembly or subsequently became detached from the luer.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation complaint due to ¿unable to draw back or flush¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual and functional testing performed by vad field assurance the following was concluded: the flow actuator was found to be missing from the luer orifice of the catheter causing the inability to aspirate and difficulty to infuse.This condition was caused during the manufacturing process and makes the device unusable for patient¿s treatment.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of reds2515 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient had an ultrasound guided 18 gauge accucath iv placed into right upper arm.Once placed, it would not draw back or flush.It was correctly placed and verified with ultrasound.The iv was removed.Once removed, md tried to flush freely through the catheter and j loop.There was quite a bit of resistance and was also unable to draw back.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 18GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10434458
• Report Number: 3006260740-2020-02983
• Device Sequence Number: 11567818
• Product Code: FOZ
• UDI-Device Identifier: 00801741110993
• UDI-Public: (01)00801741110993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: AC0182252
• Device Lot Number: REDS2515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1