MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 18G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redy1611 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during placement the powerglide catheter was difficult to advance, and the rn had to had to "pop it in".It was stated the insertion was unsuccessful and the rn had to re-stick the patient.
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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult catheter insertion was confirmed and appears to be manufacturing related.One 18 ga x 10 cm powerglide pro device was returned with product labeling indicateing lot: redy1611.The needle cover was present over the device.Microscopic observation of the distal end of the needle revealed no apparent issues with the needle bevel.Observation of the catheter revealed an irregular catheter tip.A gap was present between the catheter tip and needle shaft causing a rough transition.Photos of the sample will be forwarded to the manufacturing facility for further evaluation.Reynosa evaluation: complaint due to ¿powerglide catheter was really a struggle to advance¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual and microscopical visual performed by vad field assurance the following was concluded: the catheter tip was found to be malformed.A rough transition between the needle shaft and the catheter results in the difficulty while attempting to insert through the patient¿s skin.This condition was caused during the catheter tipping 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 redy1611 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during placement the powerglide catheter was difficult to advance, and the rn had to had to "pop it in".It was stated the insertion was unsuccessful and the rn had to re-stick the patient.

• Brand Name: DOT PG PRO 18G 10CM FULL
• 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: 9849121
• Report Number: 3006260740-2020-00882
• Device Sequence Number: 3432573
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 05/04/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: F118101
• Device Lot Number: REDY1611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1