MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER SAF-T-INTIMA 22G

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ catheter saf-t-intima 22g was defective.This was discovered during use.The following information was provided by the initial reporter: for the moment, i have been able to collect only limited information on this incident (device not kept, lot and expiry unknown, conditions and installation date not found,.).I'll come back to you when i'll have more information, and if the involvement of the catheter is proven plausible, i will not fail to communicate all the information to you in the form of an incident report that i will also transmit to the (b)(6), this incident being categorized as serious because it required surgical management to flatten a localized infectious abscess.Information received on december 19: i come back to you following the previous emails concerning an infection on saf t intima catheter.The analysis meeting revealed various points, which seemed to blame organisational and institutional shortcomings (lack of traceability of subcutaneous catheters due to the absence of appropriate computer protocols and information grids, traceability recommendations poorly known to healthcare personnel, etc.).) as well as risks related to the patient (at-risk terrain because it is polypathological, agitated and often tears off his infusions).The imputability of the material therefore seems very unlikely and in view of these various elements, since this is an isolated incident, the batch being unknown and the material not having been kept, this incident will not be the object of a declaration of materiovigilance.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Dhr could not be performed due to unknown lot#.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.H3 other text : see h.10.

Event Description

It was reported that unspecified bd¿ catheter saf-t-intima 22g was defective.This was discovered during use.The following information was provided by the initial reporter: for the moment, i have been able to collect only limited information on this incident (device not kept, lot and expiry unknown, conditions and installation date not found,.).I'll come back to you when i'll have more information, and if the involvement of the catheter is proven plausible, i will not fail to communicate all the information to you in the form of an incident report that i will also transmit to the ansm, this incident being categorized as serious because it required surgical management to flatten a localized infectious abscess.Information received on december 19: i come back to you following the previous emails concerning an infection on saf t intima catheter.The analysis meeting revealed various points, which seemed to blame organisational and institutional shortcomings (lack of traceability of subcutaneous catheters due to the absence of appropriate computer protocols and information grids, traceability recommendations poorly known to healthcare personnel, etc.).) as well as risks related to the patient (at-risk terrain because it is polypathological, agitated and often tears off his infusions).The imputability of the material therefore seems very unlikely and in view of these various elements, since this is an isolated incident, the batch being unknown and the material not having been kept, this incident will not be the object of a declaration of materiovigilance.

• Brand Name: UNSPECIFIED BD¿ CATHETER SAF-T-INTIMA 22G
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9534216
• MDR Text Key: 174490576
• Report Number: 2243072-2019-02918
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention