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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; MIDLINE CATHETER
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C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by the customer that "rn opened accucath package and the housing of the device was separated.Tried to safety the needle and spring ejected from the device.Now device is in bits and parts.".
 
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, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a separated housing was confirmed but the cause is unknown.A single photograph of a damaged 20g accucath ace deployment device and catheter was returned for evaluation of this complaint.The proximal housing had completely separated from the distal housing on the deployment device.No cracks or damage was seen to the housing joint that would indicate that excessive force or damage contributed to the event.No adhesive residue was observed at the joint.However, it is possible that adhesive was present but just not visible in the returned photograph.Possible contributing factors could include an inadequate adhesive bonded joint between the proximal and distal housing or rough shipping/storage conditions.The reported separated housing has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify any potential manufacturing related issues.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported by the customer that "rn opened accucath package and the housing of the device was separated.Tried to safety the needle and spring ejected from the device.Now device is in bits and parts".
 
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Brand Name
BARD MIDLINE
Type of Device
MIDLINE CATHETER
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 Key15934303
MDR Text Key306733742
Report Number3006260740-2022-05612
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
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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