MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA CATHETER W/SOLO VALVE TECH AND TPS 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
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 refw2533 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refw2533) have been reported from the same facility.
Event or Problem Description
It was reported "we had an issue with introducer on the triple lumen provena picc line, 5 fr.The picc rn was trying to thread the introducer in the patient and couldn¿t, nicked him with the scalpel and still couldn¿t, finally realizing there was a small burr on the end of the gray part of the introducer.Another one had to be dropped to her onto her sterile field.The first introducer felt more flimsy to the inserter.This repeated pushing trying to pop the introducer through the skin puts this covid positive patient at higher risk for dvt with that manipulation and also having to nick his skin putting him at higher risk for infection.Several skin nicks had to be made until it was realized that there was a burr on the end of the introducer.Patient is 6¿4¿, he is here and vented for covid pna.R ij in place as well and was removed once the picc line was placed." was there any patient harm reported? no, but trauma to vein and tissue as attempts made to thread introducer before the small burr on the end was noticed.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw2533 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refw2533) have been reported from the same facility.
Event or Problem Description
It was reported "we had an issue with introducer on the triple lumen provena picc line, 5 fr.The picc rn was trying to thread the introducer in the patient and couldn¿t, nicked him with the scalpel and still couldn¿t, finally realizing there was a small burr on the end of the gray part of the introducer.Another one had to be dropped to her onto her sterile field.The first introducer felt more flimsy to the inserter.This repeated pushing trying to pop the introducer through the skin puts this covid positive patient at higher risk for dvt with that manipulation and also having to nick his skin putting him at higher risk for infection.Several skin nicks had to be made until it was realized that there was a burr on the end of the introducer.Patient is 6¿4¿, he is here and vented for covid pna.R ij in place as well and was removed once the picc line was placed." was there any patient harm reported? no, but trauma to vein and tissue as attempts made to thread introducer before the small burr on the end was noticed.
Event or Problem Description
It was reported "we had an issue with introducer on the triple lumen provena picc line, 5 fr.The picc rn was trying to thread the introducer in the patient and couldn¿t, nicked him with the scalpel and still couldn¿t, finally realizing there was a small burr on the end of the gray part of the introducer.Another one had to be dropped to her onto her sterile field.The first introducer felt more flimsy to the inserter.This repeated pushing trying to pop the introducer through the skin puts this covid positive patient at higher risk for dvt with that manipulation and also having to nick his skin putting him at higher risk for infection.Several skin nicks had to be made until it was realized that there was a burr on the end of the introducer.Patient is 6¿4¿, he is here and vented for covid pna.R ij in place as well and was removed once the picc line was placed." was there any patient harm reported? no, but trauma to vein and tissue as attempts made to thread introducer before the small burr on the end was noticed.
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 review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer sheath is confirmed; however, the exact cause is unknown.One 5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal end of the microintroducer sheath was observed to be damaged.The distal end of the dilator was observed to be slightly curved.A microscopic observation revealed the edge of distal tip of the sheath was buckled and folded back and plastically deformed at the corners.While the cause of the damage observed on the introducer sheath tip is unknown, possible causes include damage during handling or use.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA CATHETER W/SOLO VALVE TECH AND TPS 5F TL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: 13600779
• Report Number: 3006260740-2022-00483
• Device Sequence Number: 1957020
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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,Followup
• Report Date (Section B): 04/12/2022

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: S1395108D
• Device Lot Number: REFW2533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 79 KG