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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
It was reported that "on the morning of (b)(6) 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
 
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez1200 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that "on the morning of february 10, 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
 
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, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the catheter was missing depth markings was confirmed and appears to be related to the manufacturing process.Photographs of sections of the 4fr s/l groshong catheter were returned for evaluation.A series of the depth markers were missing from the catheter.It could not be conclusively determined from the photographs exactly which or how many of the depth markers were missing.However, it should be noted that some of the nearby visible markings were the line markings which occur between 39cm and 59cm.The missing markings were reportedly found prior to implantation and the catheter condition in the photo was consistent with an unused device.It appeared from the photos that the catheter was improperly printed during the manufacturing process.Bd is working closely with manufacturing to help prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that "on the morning of (b)(6) 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
 
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 missing depth markers is confirmed and was determined to be manufacturing related.One 4 fr groshong clearvue catheter with a flushing hub and stiffening stylet inserted and one 4 fr two-piece groshong nxt connector were returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.The printed depth markers between 30 cm and 45 cm we observed to be missing, likely due to improper printing during the manufacturing process.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
 
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Brand Name
GROSHONG 4F SINGLE-LUMEN PICC (60CM)
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key13654109
MDR Text Key286504683
Report Number3006260740-2022-00586
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741035326
UDI-Public(01)00801741035326
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K871998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/20/2022
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 Model NumberN/A
Device Catalogue Number7717405
Device Lot NumberREEZ1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/10/2022
Initial Date FDA Received03/02/2022
Supplement Dates Manufacturer Received05/06/2022
09/20/2022
Supplement Dates FDA Received05/11/2022
09/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2020
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;
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