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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX CATHETER SET X20; EPIDURAL CATHETER

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B. BRAUN MELSUNGEN AG PERIFIX CATHETER SET X20; EPIDURAL CATHETER Back to Search Results
Catalog Number PCS-S18
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 03/04/2015
Event Type  Injury  
Event Description
As reported by the user facility (translation of user facility info by bbm sales organization in (b)(6)): catheter was broken off.
 
Manufacturer Narrative
(b)(4).The device is currently on shipping from the customer to bbm in (b)(4) for investigation.A follow up report will be provided after the investigation results are available.Imp ref # 2523676-2015-00091.
 
Manufacturer Narrative
(b)(4).We received 1 contaminated and used sample with a catheter.Investigation result.Visual inspection: the catheter was broken and it is similar to the case which caused by pull back actions.Review manufacturing records: we could not investigated our manufacturing records since we could not received batch information.We investigated inferential lots of shipped out before defect occurrence date.Justification: this complaint was not justified.
 
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Brand Name
PERIFIX CATHETER SET X20
Type of Device
EPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str.1
melsungen 34212
GM  34212
Manufacturer Contact
ludwig schuetz, safety officer m
carl-braun-str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key4649495
MDR Text Key5597766
Report Number9610825-2015-00091
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K112515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Remedial Action Other
Type of Report Initial
Report Date 08/19/2015,03/04/2015
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 Date11/05/2019
Device Catalogue NumberPCS-S18
Device Lot Number14N05H82YQ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2015
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2015
Distributor Facility Aware Date03/04/2015
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer08/19/2015
Initial Date Manufacturer Received 03/04/2015
Initial Date FDA Received03/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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