MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaz0439 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Received 4/7/17- per sales representative, the facility reported that the catheter was leaking with flushing, and at closer inspection, it had developed a hole in the catheter at the hub.The catheter was removed and replaced.No patient harm.
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter was confirmed; however, the cause was undetermined.The product returned for evaluation was one 20ga x 10 cm powerglide midline catheter.Usage residues were observed.A partially circumferential split was observed just distal of the luer hub.An attempt to infuse water through the sample using a 12 ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the site of the aforementioned split.Tactile inspection of the sample was unremarkable.Microscopic inspection of the split revealed sharply defined fracture edges.The split edges exhibited a granular texture.The observed leak was the result of catheter damage near the luer hub; however, inspection of the damage features was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors included instrument damage and contact between the catheter and the introducer needle.A lot history review (lhr) of reaz0439 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 4/7/2017- per sales representative, the facility reported that the catheter was leaking with flushing, and at closer inspection, it had developed a hole in the catheter at the hub.The catheter was removed and replaced.No patient harm.

• Brand Name: DOT PG PRO 20G 10CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6527349
• Report Number: 3006260740-2017-00528
• Device Sequence Number: 225938
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580(17)180531(10)REAZ0439
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: F120101
• Device Lot Number: REAZ0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1