MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
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 redt4147 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide leaked at extension.The clinician took off extension and put on a different extension, left for an hour and came back to the bed and it was leaking.Took off extension and no crack in extension or hub that was noticed.The clinician said that it looks like there is a dent in the hub of catheter.Changed powerglide over wire.Changed extension and no issues or leaking.
Event or Problem Description
It was reported that the powerglide leaked at extension.The clinician took off extension and put on a different extension, left for an hour and came back to the bed and it was leaking.Took off extension and no crack in extension or hub that was noticed.The clinician said that it looks like there is a dent in the hub of catheter.Changed powerglide over wire.Changed extension and no issues or leaking.
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 leakage at the connection with the powerglide catheter was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 20ga x 10cm powerglide pro rt midline catheter.Slight curved shape memory was observed along the catheter shaft.Several depressions were observed in the luer adapter.The depressions appeared to cause irregularities in the luer threads.Microscopic inspection of the luer confirmed depressions in the molded part and irregular threads.Attempts to attach non-complainant luer-lock accessories resulted in loose connections.During infusion, leakage was observed emanating from the connection.The observed leakage at the connection to the luer adapter was caused by luer irregularities that appeared to have occurred during the molding process.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation: complaint due to ¿there is a dent in the hub of catheter¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopical visual and functional testing performed by vad field assurance the following was concluded: the luer adapter of catheter was found to be deformed in the proximal end with threads damages causing the reported leakage.This condition was caused during the molding process and it makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of redt4147 showed two other similar product complaint(s) from this lot number.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM)
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9789084
• Report Number: 3006260740-2020-00733
• Device Sequence Number: 14007305
• Product Code: PND
• UDI-Device Identifier: 00801741139376
• UDI-Public: (01)00801741139376
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: ST020101D
• Device Lot Number: REDT4147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR