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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation:patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a split microintroducer is confirmed but the exact cause remains unknown.One 4 fr excaliber microintroducer was returned for evaluation.The product label indicates lot: redx2309.Blood residue was present throughout the sheath and needle.The tabs and the proximal end of the sheath were observed to split and peeled.Microscopic observation of the tabs revealed one of the sections to be fully split with the opposite section being partially split.The sheath splitting was observed to have propagated downwards.Based on the evidence of use and partial split of the tabs and sheath, possible contributing factors include resistance during advancement leading to unintentional splitting and damage during storage or handling.Since the device was found to be partially split, the complaint is confirmed but the exact factors leading to the issue could not be determined.A review of the manufacturing records did not reveal any evidence to suggest that a manufacturing-related root cause contributed to the alleged event.A lot history review (lhr) of redx2309 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported during 4fr picc placement attempt, the introducer broke prior the insertion.There was no impact to patient or any medical intervention required.On (b)(6)2022 - the sheath of the returned device was observed to be partially split.
 
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Brand Name
PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
Type of Device
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15255383
MDR Text Key305167881
Report Number3006260740-2022-03226
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741074875
UDI-Public(01)00801741074875
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K954104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/01/2022
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
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model NumberN/A
Device Catalogue Number4134105
Device Lot NumberREDX2309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2022
Initial Date FDA Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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