MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383318

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Cellulitis (1768); Erythema (1840)

Event Date 03/09/2020

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, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.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.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 patient experienced redness at insertion site, bruising, and cellulitis with an unspecified bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: (3 of 3 complaints) we had incident involving patient who received administration of rituximab via the syringe pump.Patient has developed redness at the site of administration, and two of them significant expansive bruising, one with possible cellulitis and required admission.Rituximab has been given via subq using saf-t-intima and a syringe (over slow administration) initially (no reported incidents).

Event Description

It was reported that patient experienced redness at insertion site, bruising, and cellulitis with an bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: (3 of 3 complaints) we had incident involving patient who received administration of rituximab via the syringe pump.Patient has developed redness at the site of administration, and two of them significant expansive bruising, one with possible cellulitis and required admission.

Manufacturer Narrative

The following fields have been updated with additional information: a.2.Age at time of event: 71; a.2.Date of birth:(b)(6) 1949; a.3.Sex: female; b.3.Date of event: (b)(6)2020; b.5.Describe event or problem: it was reported that patient experienced redness at insertion site, bruising, and cellulitis with an bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter: (3 of 3 complaints) we had incident involving patient who received administration of rituximab via the syringe pump.Patient has developed redness at the site of administration, and two of them significant expansive bruising, one with possible cellulitis and required admission.D.4 medical device catalog #: 383318.D.3.Medical device manufacturer: becton dickinson infusion therapy systems inc s.A.De c.V.¿ nogales, mexico / 84048.G.2 manufacturing location: becton dickinson infusion therapy systems inc s.A.De c.V.¿ nogales, mexico / 84048.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales NJ ; MX
• MDR Report Key: 9918014
• MDR Text Key: 187515897
• Report Number: 2243072-2020-00552
• Device Sequence Number: 1
• Product Code: FOZ
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383318
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR