MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 18G 8CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "attempting to insert power glide and patient complaining of unusual pain upon insertion.Unable to advance needle due to feeling resistance upon insertion.Removed device and upon further inspection the catheter appeared to be cut short and not tapered onto needle." (b)(6) 2022 - the tip of the catheter of the returned device appeared deformed.
Additional Manufacturer Narrative
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 difficulty inserting the powerglide was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.Blood residue was observed throughout the sample.The catheter was received fully assembled.The tip of the catheter appeared deformed.Microscopic inspection of the catheter confirmed tip deformation.The tip of the catheter flared away from the needle shaft.The catheter region opposite the flared portion appeared properly formed.The flared catheter tip appeared consistent with the reported difficulty/pain during device insertion; however, it could not be determined precisely when/how the catheter tip was damaged.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include improper tip formation during manufacture and damage occurring during attempted device placement due to attempted advancement against resistance.A lot history review (lhr) of refx0033 showed no other similar product complaint(s) from this lot number.

• Brand Name: DOT PG PRO 18G 8CM FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14465070
• Report Number: 3006260740-2022-01887
• Device Sequence Number: 17292264
• Product Code: FOZ
• UDI-Device Identifier: 00801741110658
• UDI-Public: (01)00801741110658
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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 Model Number: N/A
• Device Catalogue Number: F218081
• Device Lot Number: REFX0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown