MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VENFLON¿ CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/25/2021

Event Type  Injury  

Manufacturer Narrative

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 (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the port cap separated from the unspecified bd venflon¿ catheter, resulting in a 1500-2000mls hemorrhage from the cannula.The patient had to be resuscitated and an emergency c-section was performed due to fetal compromise.The baby then had to be therapeutically cooled.The following information was provided by the initial reporter: "canula inserted by medical staff and successfully and secured.Bung (white cap) came off the end of the cannula overnight.Root cause not identified on review of incident.Haemorrhage ensued.Details of injury (to patient, carer or healthcare professional): massive haemorrhage from cannula approximately 1500-2000mls.Actions: maternal resuscitation.Emergency category one caesarean section due to fetal compromise.Therapeutic cooling of baby.".

Manufacturer Narrative

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 (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the port cap separated from the unspecified bd venflon¿ catheter, resulting in a 1500-2000mls hemorrhage from the cannula.The patient had to be resuscitated and an emergency c-section was performed due to fetal compromise.The baby then had to be therapeutically cooled.The following information was provided by the initial reporter: "canula inserted by medical staff and successfully and secured.Bung (white cap) came off the end of the cannula overnight.Root cause not identified on review of incident.Haemorrhage ensued.Details of injury (to patient, carer or healthcare professional): massive haemorrhage from cannula approximately 1500-2000mls.Actions: maternal resuscitation.Emergency category one caesarean section due to fetal compromise.Therapeutic cooling of baby.".

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned for the reported issue of ¿cap loose¿ with lot number unknown regarding item # 391455, so retention samples were used for the investigation.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples and no cap loose was found.The investigation could not be done further as there is no sample no photograph and the lot number of the defective sample is not reported by the customer.The defect could not be confirmed.The root cause could not be investigated.

Event Description

It was reported that the port cap separated from the unspecified bd venflon¿ catheter, resulting in a 1500-2000mls hemorrhage from the cannula.The patient had to be resuscitated and an emergency c-section was performed due to fetal compromise.The baby then had to be therapeutically cooled.The following information was provided by the initial reporter: "canula inserted by medical staff and successfully and secured.Bung (white cap) came off the end of the cannula overnight.Root cause not identified on review of incident.Haemorrhage ensued.Details of injury (to patient, carer or healthcare professional): massive haemorrhage from cannula approximately 1500-2000mls.Actions: maternal resuscitation.Emergency category one caesarean section due to fetal compromise.Therapeutic cooling of baby.".

• Brand Name: UNSPECIFIED BD VENFLON¿ CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13584840
• MDR Text Key: 286078977
• Report Number: 2243072-2022-00262
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention