MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "floor rn was dcing pg catheter and when took dressing off arm there was no catheter attached to the hub.Could not see the catheter under the skin but patient said was tender.Did an x-ray inside the room and catheter was evident in the arm.Placement was r upper arm brachial.Did ultrasound of the area and there was a clot.Decision was to surgically remove and that is scheduled for today monday the (b)(6).Catheter was located right where insertion site was.The pg was put in by picc team." "on friday we had a patient whose powerglide was removed and the catheter was retained.We have saved the piece that came out, and the patient is going to ir today to try to remove the retained catheter." additional info.Received: was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome: patient had to undergo ultrasound and then surgical procedure for removal, hospitalization was extended (patient was in process of being discharged when retained catheter fragment discovered) and a thrombus centered around the catheter in the proximal and mid segments of the deep brachial vein was also discovered in the process of locating the catheter fragment, so heparin therapy was initiated." how was the retained segment discovered?: discovered upon removal of non-intact catheter ¿ ultrasound verified are radiographic images available.Yes.Were all the missing/broken pieces retrieved and accounted for?: yes, removed under fluoroscopy.What type of imaging was used to verify broken piece in patient?: x-ray right arm and ultrasound.Any long-term patient harm?: undetermined ¿ hospitalization extended, surgical removal of catheter, thrombus formation around catheter.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft4458 showed no other similar product complaint(s) from this lot number.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a fractured catheter is confirmed.One 10 cm powerglide pro catheter was returned for evaluation.Blood residue was visible within the components.A complete break in the catheter shaft occurred at the proximal end of the catheter extending from the hub.Two kinks were visible 2.2cm and 3.5cm from the break location.Microscopic observation of the proximal break surface a rough and uneven break.An additional angled partial split was propagating from the break surface.The distal break surface was observed to be compressed with evidence of being kinked.The characteristics of the damage suggest that kinking, tensile, and torsional stresses likely contributed to the fracturing of the catheter during use; therefore, the complaint is confirmed.
Event or Problem Description
It was reported "floor rn was dcing pg catheter and when took dressing off arm there was no catheter attached to the hub.Could not see the catheter under the skin but patient said was tender.Did an x-ray inside the room and catheter was evident in the arm.Placement was r upper arm brachial.Did ultrasound of the area and there was a clot.Decision was to surgically remove and that is scheduled for today monday the (b)(6).Catheter was located right where insertion site was.The pg was put in by picc team." "on friday we had a patient whose powerglide was removed and the catheter was retained.We have saved the piece that came out, and the patient is going to ir today to try to remove the retained catheter." additional info.Received: ¿ was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome: patient had to undergo ultrasound and then surgical procedure for removal, hospitalization was extended (patient was in process of being discharged when retained catheter fragment discovered) and a thrombus centered around the catheter in the proximal and mid segments of the deep brachial vein was also discovered in the process of locating the catheter fragment, so heparin therapy was initiated." ¿ how was the retained segment discovered?: discovered upon removal of non-intact catheter ¿ ultrasound verified are radiographic images available yes.¿ were all the missing/broken pieces retrieved and accounted for?: yes, removed under fluoroscopy.¿ what type of imaging was used to verify broken piece in patient?: x-ray right arm and ultrasound.¿ any long-term patient harm?: undetermined ¿ hospitalization extended, surgical removal of catheter, thrombus formation around catheter.

• Brand Name: FULL KIT 18G X 10 CM WITH PROBE COVER
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13826015
• Report Number: 3006260740-2022-00882
• Device Sequence Number: 17318907
• Product Code: FOZ
• UDI-Device Identifier: 00801741140617
• UDI-Public: (01)00801741140617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F218108PT
• Device Lot Number: REFT4458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 54 KG